OTC Medication Information: Help I Have a Headache
HELP I HAVE A HEADACHE — acetaminophen tablet
Help Remedies, Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Active Ingredient…………….. Purpose
(in each tablet)
Acetaminophen 325mg………….Pain reliever/fever reducer
Uses:
• temporarily relieves minor aches and pains due to
• headache
• common cold
• toothache
• backache
• muscular aches
• premenstrual and menstrual cramps
• temporarily reduces fever
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 everyday
while 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 if
you do not notice any signs or symptoms. Prompt medical attention is critical for
adults as well as for children even if you do not notice any signs or symptoms.
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
Keep out of reach of children.
If pregnant or breast feeding, ask a health professional before use.
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.
Directions
•do not take more than directed
adults and children 12 years and over | take 2 tablets every 4-6 hours as neededdo 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 neededdo not exceed 5 tablets in 24 hoursor as directed by a doctor |
children under 6 years of age | do not use this regular strength product. Thiswill provide more than the recommended dose (overdose)and may cause liver damage. |
Inactive Ingredients corn starch,microcrystalline cellulose, povidone, sodium
starch glycolate, stearic acid
Questions or comments?
Call 1-855-433-3357 10:00 AM — 5:00 PM ET, Monday-Friday
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Labeler — Help Remedies, Inc. (050359682) |
Revised: 07/2012 Help Remedies, Inc.
Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.
https://otclabels.com/lib/otc/otc-meds/help-i-have-a-headache/