Label: EXTRA STRENGTH MAPAP- acetaminophen tablet, film coated
Contains inactivated NDC Code(s)
NDC Code(s): 52959-338-00, 52959-338-10, 52959-338-12, 52959-338-20, view more52959-338-24, 52959-338-30, 52959-338-40, 52959-338-50, 52959-338-60
- Packager: H.J. Harkins Company, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0904-1983
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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.
Updated January 31, 2012
If you are a consumer or patient please visit this version.
- Active Ingredient (in each caplet)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 caplets in 24 hours,which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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
Stop use and ask a doctor if
- Pain gets worse or lasts more than 10 days
- Fever gets worse or lasts more than 3 days
- New symptoms occur
- Redness or swelling is present
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In the 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.
Do not take more than directed
Adults and children 12 years and over:
- take 2 caplets every 4 to 6 hours while symptoms last
- do not take more than 8 caplets in 24 hours
- Do not take for more than 10 days unless directed by a doctor
Children under 12 years: do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.
- Other information
- Inactive ingredients
Principal Display Panel of Extra Strength Mapap 500 mg Caplets
See New Warnings Information
STRONG PAIN &
Compare to active ingredient in Extra Strength Tylenol® Caplets*
*This product is not manufactured or distributed by McNeil Consumer Products Co., owner of the registered trademark Tylenol®.
500 mg. Each
See New Warnings Information
STRONG PAIN & FEVER RELIEF
Compare to the active ingredients in Extra Strength Tylenol® Caplets*
See New Warning Information
500 mg. Each
H.J. Harkins Company, Inc.
Nipomo, CA 93444
*This product is not manufactured or distributed by McNeil Consumer Products Co., owner of registered trademark Tylenol®
INGREDIENTS AND APPEARANCE
EXTRA STRENGTH MAPAP
acetaminophen tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52959-338(NDC:0904-1983) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape CAPSULE (Biconvex) Size 17mm Flavor Imprint Code GPI;A5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52959-338-00 100 in 1 BOTTLE 2 NDC:52959-338-10 10 in 1 BOTTLE 3 NDC:52959-338-12 12 in 1 BOTTLE 4 NDC:52959-338-20 20 in 1 BOTTLE 5 NDC:52959-338-24 24 in 1 BOTTLE 6 NDC:52959-338-30 30 in 1 BOTTLE 7 NDC:52959-338-40 40 in 1 BOTTLE 8 NDC:52959-338-50 50 in 1 BOTTLE 9 NDC:52959-338-60 60 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 05/04/2011 Labeler - H.J. Harkins Company, Inc. (147681894) Registrant - H.J. Harkins Company, Inc. (147681894) Establishment Name Address ID/FEI Business Operations H.J. Harkins Company, Inc. 147681894 repack, relabel