FDA Label for Mountain Series Weekender Medical

View Indications, Usage & Precautions

Mountain Series Weekender Medical Product Label

The following document was submitted to the FDA by the labeler of this product Tender Corporation Dba Adventure Medical Kits. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 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 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 use

  • if 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 directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless
    directed 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 CHINA

20130301

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 nonprescription
    NSAIDs (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 information

        • read 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

Package Label.Principal Display Panel



Antiseptic Towelette

Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

Genuine Triple Antibiotic

First Aid Ointment

To Help Prevent Infection

Each Gram Contains:

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg

(equivalent to 3.5 mg

Neomycin base)

 Polymyxin B Sulfate 5000 units

Net Wt. 0.5g ; (1/64 oz)

Manufactured in CHINA for

GENUINE FIRST AID.



Triple Antibiotic Ointment 10pcs

Net wt. 0.9g (1/32oz)



100
Triple Antibiotic


Active Ingredients



Active Ingredient: .........Bacitracin Zinc 400 units

Neomycin 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

Uses

Temporarily 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 ingredients

carnauba 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 with

  • headache
  • 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 with

    • headache
    • 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 59°-86°F (15°-30°C)
  • avoid excessive heat and humidity
  • 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
      • store at room temperature 59°-86°F (15°-30°C)
      • tamper-evident sealed packets
      • do not use any opened or torn packets

Questions Or Comments?



1-800-634-7680


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



Purpose

Pain reliever/fever reducer

Antiseptic


Otc - Ask 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

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug

Otc - When Using



When using this product

  • take with food or milk if stomach upset occurs

Dosage & Administration



Directions

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

Otc - Questions



Questions or comments? 1-800-634-7680


Principal Display Panel



Medi-First®
Ibuprofen 200 mg
Pain Reliever/Fever Reducer (NSAID)
Easy To Swallow Film Coated Tablets
See new warnings information
100 tablets (50 x 2)
Compare active ingredient to: Genuine Advil®
Registered trademark Wyeth Consumer
Tamper Evident Unit Dose Packets


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 use

  • if allergic to iodine
  • in the eyes
  •             For external use only

                Ask a doctor before use if injuries are

    • deep or puncture wounds
    • serious burns
    •             Stop use and ask a doctor if

      • redness, irritation, swelling or pain persists or increases
      • infection 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.