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 overtake 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 agetake 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 agedo 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

HeadacheLabel
(click image for full-size original)
HELP I HAVE A HEADACHE acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49260-710
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CELLULOSE, MICROCRYSTALLINE
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
Product Characteristics
Color white (white) Score no score
Shape OVAL (Oval Tablet) Size 18mm
Flavor Imprint Code h;help
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49260-710-20 20 TABLET (TABLET) in 1 BLISTER PACK None
2 NDC:49260-710-50 50 TABLET (TABLET) in 1 BOTTLE None
3 NDC:49260-710-02 2 TABLET (TABLET) in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 05/01/2012
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.

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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.

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