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

ACETAMINOPHEN SINUS CONGESTION AND PAIN by

Drug Labeling and Warnings

ACETAMINOPHEN SINUS CONGESTION AND PAIN by is a Otc medication manufactured, distributed, or labeled by A P J Laboratories Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACETAMINOPHEN 325 mg

PHENYLEPHRINE HYDROCHLORIDE 5mg

PURPOSE

Alleviates Sinus Headache & Pain (Acetaminophen)

Relieves Sinus Pressure Clears Nasal Congestion (Phenylephrine HCl)

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

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

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

■ 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

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 tablet

Product 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)