NDC 49260-710 Help I Have A Headache

NDC Product Code 49260-710

NDC 49260-710-02

Package Description: 2 TABLET in 1 POUCH

NDC 49260-710-20

Package Description: 20 TABLET in 1 BLISTER PACK

NDC 49260-710-50

Package Description: 50 TABLET in 1 BOTTLE

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

NDC Product Information

Help I Have A Headache with NDC 49260-710 is a product labeled by Help Remedies, Inc.. The generic name of Help I Have A Headache is . The product's dosage form is and is administered via form.

Labeler Name: Help Remedies, Inc.

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.

  • STARCH, CORN (UNII: O8232NY3SJ)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POVIDONE (UNII: FZ989GH94E)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

Product Labeler Information

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

Labeler Name: Help Remedies, Inc.
Labeler Code: 49260
Start Marketing Date: 05-01-2012 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’.

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Information for Patients

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
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Help I Have A Headache Product Label Images

Help I Have A Headache 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

Otc - Active Ingredient

Active Ingredient................. Purpose(in each tablet)Acetaminophen 325mg.............Pain reliever/fever reducer

Otc - Purpose

Uses:• temporarily relieves minor aches and pains due to• headache • common cold • toothache • backache • muscular aches• premenstrual and menstrual cramps• temporarily reduces fever

Warnings

Warnings: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.• child takes more than 5 tablets in 24 hours• taken with other drugs containing acetaminophen.• adult has 3 or more alcoholic drinks everydaywhile using this product.Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even ifyou do not notice any signs or symptoms. Prompt medical attention is critical foradults as well as for children even if you do not notice any signs or symptoms.

Otc - Do Not Use

Do not use • with any other drug containing acetaminophen (prescription or non-prescription) If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist• if you are allergic to acetaminophen or any of the inactive ingredients in this productAsk a doctor before use if the user has liver disease.Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.Stop use and ask a doctor if• pain gets worse or lasts for more than 10 days in adults and childre• fever gets worse or lasts for more than 3 days• any new symptoms occur• redness or swelling is presentThese could be signs of a serious condition

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Pregnancy Or Breast Feeding

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

Dosage & Administration

Other Information • do not use if packet is torn, cut or opened • store at controlled room temperature 15-30 degrees celcius (59-86 degrees fahrenheits) • avoid excessive heat and humidity • keep package.It contains important information.

Indications & Usage

Directions•do not take more than directedadults and children 12 years and overtake 2 tablets every 4-6 hours as neededdo not exceed 12 tablets in 24 hours or as directed by doctorchildren 6-11 years of agetake 1 tablet every 4-6 hours as neededdo not exceed 5 tablets in 24 hoursor as directed by a doctorchildren under 6 years of agedo not use this regular strength product. Thiswill provide more than the recommended dose (overdose)and may cause liver damage.

Inactive Ingredient

Inactive Ingredients corn starch,microcrystalline cellulose, povidone, sodiumstarch glycolate, stearic acid

Otc - Questions

Questions or comments?Call 1-855-433-335710:00 AM - 5:00 PM ET, Monday-Friday

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