HELP I HAVE A HEADACHE- acetaminophen tablet

Help I Have a Headache by

Drug Labeling and Warnings

Help I Have a Headache by is a Otc medication manufactured, distributed, or labeled by Help Remedies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient................. Purpose
(in each tablet)

Acetaminophen 325mg.............Pain reliever/fever reducer

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 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

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

Keep out of reach of children.

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

QUESTIONS

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HELP I HAVE A HEADACHE 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49260-710
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

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

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	Marketing Start Date	Marketing End Date
1	NDC: 49260-710-20	20 in 1 BLISTER PACK
2	NDC: 49260-710-50	50 in 1 BOTTLE
3	NDC: 49260-710-02	2 in 1 POUCH

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)