ACETAMINOPHEN SINUS CONGESTION AND PAIN description, usages, side effects, indications, overdosage, supplying and lots more!

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ACETAMINOPHEN SINUS CONGESTION AND PAIN

A P J Laboratories Limited
A P J Laboratories Limited


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

Uses

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

ACETAMINOPHEN SINUS CONGESTION AND PAIN

ACETAMINOPHEN SINUS CONGESTION AND PAIN

ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:46084-101
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
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 Characteristics

Color Size Shape
white 18 mm OVAL

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
part part341 2013-06-06


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Be sure to consult your doctor before taking any medication!
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