NDC | 46084-101-30 |
Set ID | 44a25c50-b16b-407c-99ea-668afca25924 |
Category | HUMAN OTC DRUG LABEL |
Packager | A P J Laboratories Limited |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
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
-
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
-
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)