Label: ACETAMAX PM- acetaminophen,diphenhydramine hcl tablet, effervescent
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Contains inactivated NDC Code(s)
NDC Code(s): 13411-855-16, 13411-855-20, 13411-855-24 - 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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- Active Ingredients
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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 productAllergy 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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• with any other product containing diphenhydramine, even one used on skin
• in children under 12 years of age
• if you have ever had an allergic reaction to this product or any of its ingredientsAsk a doctor before use if you have
• a sodium-restricted diet.
• liver disease
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland
• glaucomaAsk a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizersWhen using this product
• drowsiness will occur
• avoid alcoholic drinks
• do not drive a motor vehicle or operate machineryStop use and ask a doctor if
• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• These could be signs of a serious condition.If pregnant or breast-feeding,
ask a health professional before use.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. - Keep out of reach of children.
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INGREDIENTS AND APPEARANCE
ACETAMAX PM
acetaminophen,diphenhydramine hcl tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13411-855 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DIPHENHYDRAMINE (UNII: 8GTS82S83M) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE 25 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) DIMETHICONE (UNII: 92RU3N3Y1O) MANNITOL (UNII: 3OWL53L36A) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) POLYSORBATE 20 (UNII: 7T1F30V5YH) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM CARBONATE (UNII: 45P3261C7T) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) 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:13411-855-16 16 in 1 BOX 08/31/2020 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:13411-855-20 20 in 1 BOX 08/31/2020 2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:13411-855-24 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(13411-855)