ALLERGY SINUS, LIL DRUG STORE- acetaminophen, phenylephrine hydrochloride, chlorpheniramine maleate tablet

Allergy Sinus, Lil Drug Store by

Drug Labeling and Warnings

Allergy Sinus, Lil Drug Store by is a Otc medication manufactured, distributed, or labeled by Lil' Drug Store Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

​Drug Facts

Active ingredients

Active ingredients (in each tablet)

Acetamionophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine Hydrochloride 5 mg

Purpose

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Uses

Uses

• temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
• headache
• sinus congestion and pressure
• nasal congestion
• runny nose and sneezing
• minor aches and pains
• temporarily relieves these additional symptoms of hay fever:
• itching of the nose or throat
• itchy, watery eyes
• helps clear nasal passages
• helps decongest sinus openings and passages

Warnings

​Warnings

Liver warning

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4,000 mg of acetaminophen 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.

Allergy alert

Allergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor

Ask a doctor before use if you have

• liver disease
• heart disease
• glaucoma
• diabetes
• thyroid disease
• high blood pressure
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor before use if you are

Ask a doctor before use if you are

• taking sedatives or tranquilizers.
• taking the blood thinning drug warfarin.

When using this product

When using this product

• do not exceed recommended dosage
• excitability may occur, especially in children
• drowsiness may occur
• alcohol, sedatives and tranquilizers may increase drowsiness
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur
• pain or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur These could be signs of a serious condition.

If pregnant or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Directions

• do not take more than directed

• adults and children 12 years and over:
  • take 2 tablets every 4 to 6 hours as needed
  • do not take more than 12 tablets in 24 hours or as directed by a doctor
• children under 12 years of age:
  • ask a doctor

Other information

Other information

• store at room temperature 59-86°F (15-30°C)
• avoid excessive heat and humidity

Inactive ingredients

Inactive ingredients
corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

Questions or comments?

Questions or comments?
call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Allergy Sinus, Lil' Drug Store ® - PDP/Package

[caduceus]

on

the

Go

PACKS

Allergy

Sinus [tablets image]

Allergy Sinus

Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride

Pain Reliever, Antihistamine, Nasal Decongestant

Relief of

• Sinus Congestion & Pressure
• Nasal Congestion
• Runny Nose & Sneezing

6

Tablets

​ 3POUHES, 2 TABLETS PER POUCH

[Lil' Drug Store logo]

INGREDIENTS AND APPEARANCE

ALLERGY SINUS, LIL DRUG STORE 
acetaminophen, phenylephrine hydrochloride, chlorpheniramine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-9927
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
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	AZ;275
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-9927-3	3 in 1 CARTON	02/08/2011
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	02/08/2011

Labeler - Lil' Drug Store Products, Inc. (093103646)