Label: MAPAP EXTRA STRENGTH- acetaminophen capsule
- NDC Code(s): 0904-1987-60, 0904-1987-80
- Packager: Major Pharmaceuticals
- 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 May 19, 2020
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- Drug Facts
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- with any other drugs containing acetaminophen (prescription or nonprescription). 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
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Directions
Do not take more than directed (see overdose warning).
adults and children 12 years and over:
- take 2 capsules every 6 hours while symptoms last
- Do not take more than 6 capsules in 24 hours,unless directed by a doctor
- Do not take for more than 10 days unless directed by a doctor
children under 12 years: ask a doctor
- Other information
- Inactive Ingredients
- Questions?
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MAPAP EXTRA STRENGTH
acetaminophen capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-1987 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 FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) POVIDONE K30 (UNII: U725QWY32X) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white, red Score no score Shape CAPSULE Size 22mm Flavor Imprint Code CPC;617 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-1987-60 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/22/1997 2 NDC:0904-1987-80 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/29/2001 04/30/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 12/22/1997 Labeler - Major Pharmaceuticals (191427277)