Label: HELP I HAVE A HEADACHE- acetaminophen tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 49260-710-02, 49260-710-20, 49260-710-50 - Packager: Help Remedies, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated July 9, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
-
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
- PREGNANCY OR BREAST FEEDING
- DOSAGE & ADMINISTRATION
-
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
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HELP I HAVE A HEADACHE
acetaminophen tabletProduct 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)
