Otc - Active Ingredient
Active Ingredient................. Purpose(in each tablet)Acetaminophen 325mg.............Pain reliever/fever reducer
Help I Have A Headache
FDA Label NDC 49260-710
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Help Remedies, Inc. for the product Help I Have A Headache (NDC 49260-710). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 product
Ask 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 present
These 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 directed
| adults and children 12 years and over | take 2 tablets every 4-6 hours as needed do not exceed 12 tablets in 24 hours or as directed by doctor |
| children 6-11 years of age | take 1 tablet every 4-6 hours as needed do not exceed 5 tablets in 24 hours or as directed by a doctor |
| children under 6 years of age | do not use this regular strength product. This will provide more than the recommended dose (overdose) and may cause liver damage. |
Inactive Ingredient
Inactive Ingredients corn starch,microcrystalline cellulose, povidone, sodium
starch 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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