NDC 44224-0118 Mountain Series Weekender Medical

NDC Product Code 44224-0118

NDC 44224-0118-1

Package Description: 1 KIT in 1 KIT * .8 mL in 1 PACKAGE (52124-0001-1) * .5 g in 1 TUBE (52124-0003-1) * 2 TABLET, FILM COATED in 1 PACKET (47682-116-99) * 1 CAPSULE in 1 PACKET (47682-182-46) * 2 TABLET, FILM COATED in 1 PACKET (47682-808-99) * 2 TABLET, FILM COATED in 1 PACKET (47682-145-99) * 22 g in 1 PACKET (52380-0001-3)

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Mountain Series Weekender Medical with NDC 44224-0118 is a product labeled by Tender Corporation Dba Adventure Medical Kits. The generic name of Mountain Series Weekender Medical is . The product's dosage form is and is administered via form.

Labeler Name: Tender Corporation Dba Adventure Medical Kits

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • WATER (UNII: 059QF0KO0R)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • D&C RED NO. 28 (UNII: 767IP0Y5NH)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GELATIN (UNII: 2G86QN327L)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • LACTOSE (UNII: J2B2A4N98G)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYDEXTROSE (UNII: VH2XOU12IE)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIACETIN (UNII: XHX3C3X673)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • NONOXYNOL-9 (UNII: 48Q180SH9T)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Tender Corporation Dba Adventure Medical Kits
Labeler Code: 44224
Start Marketing Date: 08-01-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Mountain Series Weekender Medical Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Active Ingredient:                         Benzalkonium Chloride 0.40%

Purpose

Antiseptic

Triple Antibiotic

Pain reliever/fever reducer

Antihistamine

Pain reliever/fever reducer

Use

For Professional and Hospital use.  Helps prevent infection.  Antiseptic cleansing of face, hands and body without soap and water.

Warnings

Warning:   For external use only.

For external use only.



Warnings

Otc - Keep Out Of Reach Of Children

Keep out of reach of children:  If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.If ingested, contact a Poison Control Center right away.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Keep out of the reach of children. In case of overdose, contact a physician or poison control center immediately.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Otc - Stop Use

Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.

Stop use and consult a doctor:if the condition persists or gets worse;  a rash or other allergic reaction develops

  • Stop use and ask a doctor ifyou experience any of the following signs of stomach bleeding:feel faint
  • Vomit blood
  • Have bloody or black stools
  • Have stomach pain that does not get better
  • Pain gets worse or lasts for more than 10 days
  • Fever gets worse or lasts for more than 3 days
  • Redness or swelling is present in the painful area
  • Any new or unexpected symptoms occur

Otc - Do Not Use

Do not use in the eyes or over large areas of the body.

Do not use:  in eyes;  over large areas of the body; If allergic to any of the ingredients;  for more than one week unless directed by a physician.

  • Do not useif you have ever had an allergic reaction to any other pain reliever/fever reducer
  • Right before or after heart surgery

Directions

Tear open packet, unfold towelette and use to cleanse desired skin area.  Discard towelette appropriately after single use.

Directions: clean affected area;  apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage

  • Do not take more than directedthe smallest effective dose should be used do not take longer than 10 days, unlessdirected by a doctor (see Warnings)
  • Drink a full glass of water with each dose

  • Do not use more than directed

  • Do not use more than directed

Inactive Ingredients

Inactive Ingredient:   Purified water

Croscarmellose sodium*, hypromellose, microcrystalline cellulose*, mineral oil*, polyethylene glycol*, propylene glycol*, starch, titanium dioxide*
*may contain

D&C Red #28, FD&C Blue #1, FD&C Red #40, gelatin, starch

Corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone, pregelatinized starch*, sodium starch glycolate, stearic acid
* may contain

Other

LOT/EXP:                           Made in CHINA20130301

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

  • Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
  • Are age 60 or older
  • Have had stomach ulcers or bleeding problems
  • Take a blood thinning (anticoagulant) or steroid drug
  • Take other drugs containing prescription or nonprescriptionNSAIDs (aspirin, ibuprofen, naproxen, or others)
  • Have 3 or more alcohol drinks every day while using this product
  • Take more or for a longer time than directed

Adults and children: (12 years and older): Take 1 to 2 capsules every 4 to 6 hours as needed. Do not take more than 12 capsules in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

  • Allergy alert: Ibuprofen may cause a severe allergic reaction which may include:
  • Hives
  • Asthma (wheezing)
  • Rash
  • Blisters
  • Skin reddening
  • Facial swelling
  • Shock
  • If an allergic reaction occurs, stop use and seek medical help right away.

  • Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
  • Are age 60 or older
  • Have had stomach ulcers or bleeding problems
  • Take a blood thinning (anticoagulant) or steroid drug
  • Take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • Have 3 or more alcoholic drinks every day while using this product
  • Take more or for a longer time than directed

Adults and children: (12 years and older)Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor.

Children under 12 years:Do not give to children under 12 years of age.

  • Other informationread all product information before using
  • Store at 68-77°F (20-25°C)
  • Avoid excessive heat 40°C (above 104°F)
  • Tamper evident sealed packets
  • Do not use any opened or torn packets

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
  • More than 12 tablets in 24 hours, which is the maximum daily amount
  • With other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Active Ingredients

Active Ingredient: .........Bacitracin Zinc 400 unitsNeomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)Polymyxin B Sulfate 5000 units

(in each capsule)
Diphenhydramine Hydrochloride 25 mg

Indications & Usage

Uses:  To help prevent infection in: minor cuts;  scrapes;  burns

  • UsesTemporarily relieves minor aches and pains associated with■
  • Headache
  • Backache
  • Common cold
  • Minor arthritis pain
  • Toothache
  • Menstrual cramps
  • Muscular aches
  • Temporarily reduces fever.

Storage And Handling

Other information:Store at room temperature.

Inactive Ingredient

Water

Inactive ingredientscarnauba wax*, cellulose*, colloidal silicon dioxide, corn starch*, hypromellose, iron oxide red*, lactose, magnesium stearate, microcrystalline cellulose*, polydextrose, polyethylene glycol, povidone, silica*, sodium lauryl sulfate*, sodium starch glycolate, stearic acid*, titanium dioxide, triacetin**may contain

Active Ingredient (In Each Tablet)

Aspirin (NSAID*) 325 mg
*nonsteroidal anti-inflammatory drug

Acetaminophen 325 mg

Uses

  • Temporarily relieves minor aches and pains associated withheadache
  • Minor arthritis
  • Common cold
  • Menstrual cramps
  • Muscular aches
  • Backache
  • Toothache
  • Temporarily reduces fever.

Temporarily relieves runny nose and decreases sneezing, itching of the nose and throat, itchy-watery eyes due to hay fever or other respiratory allergies.

  • For the temporary relief of minor aches and pains associated withheadache
  • Common cold
  • Muscular aches
  • Toothache
  • Minor arthritis pain
  • Menstrual cramps
  • For the reduction of fever.

Do Not Use

  • If you have ever had an allergic reaction to any other pain reliever/ fever reducer
  • Right before or after heart surgery
  • If you are taking prescription drugs for gout, diabetes or arthritis

  • With any other product containing diphenhydramine, even one that is used on skin.

  • With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • For more than 10 days for pain unless directed by a doctor
  • For more than 3 days for fever unless directed by a doctor

Ask A Doctor Before Use If

  • Stomach bleeding warning applies to you
  • You have a history of stomach problems such as heartburn
  • You have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • You are taking a diuretic

Ask A Doctor Or Pharmacist Before Use If You Are

  • Under a doctor's care for any serious condition
  • Taking any other drug

  • Taking any drugs for asthma
  • Taking sedatives or tranquilizers

When Using This Product

  • Take with food or milk if stomach upset occurs

  • Marked drowsiness may occur
  • Avoid alcohol beverages
  • Alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • Use caution when driving a motor vehicle or operating machinery
  • Excitability may occur, especially in children

Stop Use And Ask A Doctor If

  • You experience any of the following signs of stomach bleeding:
  • Feel faint
  • Vomit blood
  • Have bloody or black stools
  • Have stomach pain that does not get better
  • Pain gets worse or lasts more than 10 days
  • Fever gets worse or lasts more than 3 days
  • You have difficulty swallowing
  • If ringing in the ears or loss of hearing occurs redness or swelling is present in the painful area
  • Any new symptoms appear

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

If pregnant or breast feeding, ask a health professional before use.

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to so by a doctor because it may cause problems in the unborn child or complications during delivery.

If pregnant or breast-feeding, ask a health professional before use.

Adults And Children: (12 Years And Older)

Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor.

Take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours.

Children Under 12 Years:

Do not give to children under 12 years of age.

Do not give to children under 12 years of age.

Other Information

  • Read all product information before using
  • Store at room temperature 59º-86ºF (15º-30ºC)
  • Avoid excessive heat and humidity
  • Tamper evident sealed packets
  • Do not use any opened or torn packets

  • Store at room temperature 59º-86ºF (15º-30ºC)
  • Tamper-evident sealed packets
  • Do not use any opened or torn packets

  • Store at room temperature 59°-86°F (15°-30°C)
  • Tamper-evident sealed packets
  • Do not use any opened or torn packets

116R Medique Apap 325 Mg Label

Medique®
Aspirin
5 Grain (325 mg)
Pain Reliever/Fever Reducer (NSAID)
See new warnings information
East To Swallow
Film Coated Tablets
24 Tablets
(12 x 2)
Compare active ingredients to Bayer®
Registered Trademark Bayer Consumer
Tamper Evident Unit Dose Packets

Ask A Doctor Before Use If You Have

  • A breathing problem such as emphysema or chronic bronchitis
  • Difficulty in urination due to enlargement of the prostate gland
  • Glaucoma

  • Liver disease

182R Medique Diphen Label

Collect Medi-Bucks
See inside flap for more details
Medique®
Diphen
Diphenhydramine HCl 25 mg
Hay Fever/Allergies
Fiebre del Heno/Alergias
Pull to Open
TiraParaAbrir
Easy To Swallow Capsules
Capsulas Faciles de Tragar
200 Capsules
(200 x 1)
Tamper Evident Unit Dose Packets
Empaquetado con Sellado Evidente en Dosis Untarias

Otc - Active Ingredient

Active ingredient(in each tablet)Ibuprofen (NSAID*) 200 mg
*nonsteroidal anti-inflammatory drug

Povidone-iodine 10%

Otc - Purpose

PurposePain reliever/fever reducer

Antiseptic

Otc - Ask Doctor

  • Ask a doctor before use ifstomach bleeding warning applies to you
  • You have a history of stomach problems such as heartburn
  • You have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • You are taking a diuretic

Otc - Ask Doctor/Pharmacist

  • Ask a doctor or pharmacist before use if you aretaking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • Taking any other drug

Otc - When Using

  • When using this producttake with food or milk if stomach upset occurs

Dosage & Administration

  • Directionsdo not use more than directedthe smallest effective dose should be useddo not take longer than 10 days, unless directed by a doctor (see Warnings)

Otc - Questions

Questions or comments? 1-800-634-7680

Ask A Doctor Or Pharmacist Before Use If

  • You are taking the blood thinning drug warfarin

Stop Using And Ask A Doctor If

  • Symptoms do not improve
  • New symptoms occur
  • Pain or fever persists or gets worse
  • Redness or swelling is present

145R Medique Apap 325 Mg Label

Collect MediBucks
See inside flap for more details
Medique®APAP
Acetaminophen 325 mg
Pain Reliever/Fever Reducer
Alivia el Dolor/Reduce la Fiebre
Easy To Swallow
Film Coated Tablets
Facil de Tragar Tabletas con Cubierta Pelicular
Pull to Open
Tire Para Abrir
See new warnings information
500 Tablets
(250 x 2)
Tamper Evident Unit Dose Packets
Empaquetado con Sellado Evidente en Dosis Unitarias

Weekender Kit Label

Mountain Series Medical Kit Weekender

Adventure Medical Kits BE SAFE
1-6 People up to 7 days

Warnings And Precautions

  • Warnings            Do not useif
  • Allergic to iodinein
  • The eyes            For
  • External use only            Ask a
  • Doctor before use if injuries aredeep
  • Or puncture woundsserious
  • Burns            Stop use
  • And ask a doctor ifredness,
  • Irritation, swelling or pain persists or increasesinfection
  • Occurs            Avoid
  • Pooling beneath patient            Keep out of
  • Reach of children.  In case of accidental
  • Ingestion, seek professionalassistance
  • Or consult a poison control center immediately.

* Please review the disclaimer below.