Medication Guide App

Help I Have a Headache

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: Help Remedies, Inc.
NDC Code: 49260-710

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.

Drug Facts


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 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 Ingredients corn starch,microcrystalline cellulose, povidone, sodium
starch glycolate, stearic acid

Questions or comments?

Call 1-855-433-335710:00 AM - 5:00 PM ET, Monday-Friday



HELP I HAVE A HEADACHE 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49260-710
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
Colorwhite (white) Scoreno score
ShapeOVAL (Oval Tablet) Size18mm
FlavorImprint Codeh;help
Contains    
Packaging
#Item CodePackage Description
1NDC:49260-710-2020 TABLET (TABLET) in 1 BLISTER PACK
2NDC:49260-710-5050 TABLET (TABLET) in 1 BOTTLE
3NDC:49260-710-022 TABLET (TABLET) in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/01/2012
Labeler - Help Remedies, Inc. (050359682)

Revised: 07/2012
 
Help Remedies, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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