ACETAMINOPHEN SINUS CONGESTION AND PAIN A P J COATED- acetaminophen, 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

•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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore2 pieces
ShapeOVALSize18mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46084-101-3030 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/06/2013
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: 6/2013
Document Id: 529b0e8e-4f74-4d96-b9dc-c57ba66162d3
Set id: 44a25c50-b16b-407c-99ea-668afca25924
Version: 4
Effective Time: 20130606
 
A P J Laboratories Limited