Label: ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED- acetaminophen, phenylephrine hydrochloride tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 46084-101-30 - Packager: A P J Laboratories Limited
- 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.
Drug Label Information
Updated June 6, 2013
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take
■ more than 12 gelcaps 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
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.
- Directions
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INACTIVE INGREDIENT
•CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
•CELLULOSE, MICROCRYSTALLINE
•STARCH, CORN
•BUTYLATED HYDROXYTOLUENE
•METHYLPARABEN
•PROPYLPARABEN
•SODIUM STARCH GLYCOLATE TYPE A POTATO
•TALC
•MAGNESIUM STEARATE
•SALICYLIC ACID
•CROSCARMELLOSE SODIUM
•SODIUM LAURYL SULFATE
•ISOPROPYL ALCOHOL
•METHYLENE CHLORIDE
•TITANIUM DIOXIDE
•HYPROMELLOSES
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED
acetaminophen, phenylephrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46084-101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) 160 mg CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) 120 mg STARCH, CORN (UNII: O8232NY3SJ) 30 mg BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .5 mg METHYLPARABEN (UNII: A2I8C7HI9T) .8 mg PROPYLPARABEN (UNII: Z8IX2SC1OH) .4 mg SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) 20 mg TALC (UNII: 7SEV7J4R1U) 15 mg MAGNESIUM STEARATE (UNII: 70097M6I30) 13 mg SALICYLIC ACID (UNII: O414PZ4LPZ) 4 mg CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 7 mg SODIUM LAURYL SULFATE (UNII: 368GB5141J) 2 mg ISOPROPYL ALCOHOL (UNII: ND2M416302) 130 mg METHYLENE CHLORIDE (UNII: 588X2YUY0A) 280 mg TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 1.5 mg HYPROMELLOSES (UNII: 3NXW29V3WO) 3 mg Product Characteristics Color white Score 2 pieces Shape OVAL Size 18mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46084-101-30 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/06/2013 Labeler - A P J Laboratories Limited (677378339) Registrant - A P J Laboratories Limited (677378339) Establishment Name Address ID/FEI Business Operations A P J Laboratories Limited 677378339 manufacture(46084-101)
