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

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.

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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 TypeHUMAN OTC DRUGItem Code (Source)NDC:46084-101
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS160 mg
CELLULOSE, MICROCRYSTALLINE120 mg
STARCH, CORN30 mg
BUTYLATED HYDROXYTOLUENE.5 mg
METHYLPARABEN.8 mg
PROPYLPARABEN.4 mg
SODIUM STARCH GLYCOLATE TYPE A POTATO20 mg
TALC15 mg
MAGNESIUM STEARATE13 mg
SALICYLIC ACID4 mg
CROSCARMELLOSE SODIUM7 mg
SODIUM LAURYL SULFATE2 mg
ISOPROPYL ALCOHOL130 mg
METHYLENE CHLORIDE280 mg
TITANIUM DIOXIDE1.5 mg
HYPROMELLOSES3 mg
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize18mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:46084-101-3030 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/02/2013
Labeler - A P J Laboratories Limited (677378339)
Registrant - A P J Laboratories Limited (677378339)
Establishment
NameAddressID/FEIBusiness Operations
A P J Laboratories Limited677378339manufacture(46084-101)

Revised: 05/2013
 
A P J Laboratories Limited