Label: ACETAMAX- acetaminophen 500 mg tablet, effervescent
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Contains inactivated NDC Code(s)
NDC Code(s): 13411-854-16, 13411-854-20, 13411-854-24 - Packager: Advanced Pharmaceutical Services, Inc. Dba Affordable Quality 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 August 31, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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Warnings
Alcohol warning: if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/ fever reducers.
Acetaminophen may cause liver damage.
Do not use with any other product containing acetaminophen
Ask a doctor before use if you have
• a sodium-restricted diet
• any liver, kidney, or heart disease
• high blood pressureAsk a doctor or pharmacist before use if you are
• allergic or sensitive to any tablet ingredients
• pregnant, breastfeeding or may become pregnant
When using this product
• do not exceed the recommend dosageStop use and ask a doctor if
• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days.If pregnant, may become pregnant, or breastfeeding, ask a health professional before use.
- KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.
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Directions
• do not take more than directed (see overdose warning)
Adults and children 12 years and over
• take two tablets fully dissolved in 8 oz of water every 4 to 6 hours as needed.
• do not take more than 8 tablets in 24 hours.
• do not use more than 10 days unless directed by a doctor.
Children under 12 years do not use this adult product; this will provide more than the dose (overdose) of pain reliever and may cause liver damage. - Other information
- Inactive Ingredients
- Image
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INGREDIENTS AND APPEARANCE
ACETAMAX
acetaminophen 500 mg tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13411-854 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) DIMETHICONE (UNII: 92RU3N3Y1O) DOCUSATE SODIUM (UNII: F05Q2T2JA0) GINGER OIL (UNII: SAS9Z1SVUK) WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED) MANNITOL (UNII: 3OWL53L36A) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM CARBONATE (UNII: 45P3261C7T) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 22mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13411-854-16 16 in 1 BOX 08/31/2020 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:13411-854-20 20 in 1 BOX 08/31/2020 2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:13411-854-24 24 in 1 BOX 08/31/2020 3 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 08/31/2020 Labeler - Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals (187498279) Establishment Name Address ID/FEI Business Operations S.P.M CORPORATION 555279715 manufacture(13411-854)
