DrugCite

ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED - acetaminophen and phenylephrine hydrochloride tablet 
A P J Laboratories Limited

ACETAMINOPHEN 325 mg

PHENYLEPHRINE HYDROCHLORIDE 5mg

•Alleviates Sinus Headache & Pain (Acetaminophen)

•Relieves Sinus Pressure Clears Nasal Congestion (Phenylephrine HCl)

Keep out of reach of children.

for the temporary relief of:

• headache

•sinus

•congestion and pressurenasal congestion

•minor aches and pains

•helps decongest sinus openings and passages

•promotes sinus drainage

•helps clear nasal passages

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

■ Do not take more than directed (see overdose warning)

■ Adults and children 12 years and over take 2 gelcaps every 4 hoursdo not take more than 12 gelcaps in 24 hours

■ Children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the

•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

Product


ACETAMINOPHEN SINUS CONGESTION AND PAIN  A P J COATED
acetaminophen, phenylephrine hydrochloride  tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 46084-101
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 160 mg
CELLULOSE, MICROCRYSTALLINE 120 mg
STARCH, CORN 30 mg
BUTYLATED HYDROXYTOLUENE .5 mg
METHYLPARABEN .8 mg
PROPYLPARABEN .4 mg
SODIUM STARCH GLYCOLATE TYPE A POTATO 20 mg
TALC 15 mg
MAGNESIUM STEARATE 13 mg
SALICYLIC ACID 4 mg
CROSCARMELLOSE SODIUM 7 mg
SODIUM LAURYL SULFATE 2 mg
ISOPROPYL ALCOHOL 130 mg
METHYLENE CHLORIDE 280 mg
TITANIUM DIOXIDE 1.5 mg
HYPROMELLOSES 3 mg
Product Characteristics
Color white Score no score
Shape OVAL Size 18mm
Flavor Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 46084-101-30 30  In 1 BLISTER PACK None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 05/02/2023

Labeler - A P J Laboratories Limited (677378339)
Registrant - A P J Laboratories Limited (677378339)
Establishment
Name Address ID/FEI Operations
A P J Laboratories Limited 677378339 manufacture
Revised: 05/2013A P J Laboratories Limited