Allergy Sinus, Lil' Drug Store ®

Allergy Sinus, Lil' Drug Store ®
SPL v1
SPL
SPL Set ID 1145440e-b37a-6e5e-e063-6294a90ab4a0
Route
ORAL
Published
Effective Date 2011-02-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Phenylephrine (5 mg) Chlorpheniramine (2 mg)
Inactive Ingredients
Starch, Corn Crospovidone (15 Mpa.s At 5%) Stearic Acid Hypromellose, Unspecified Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: AZ;275 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-02-08

Description

​Drug Facts

Purpose

Purpose Pain reliever Antihistamine Nasal decongestant


Medication Information

Purpose

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Description

​Drug Facts

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

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

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.
Drug Facts

​Drug Facts

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
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.

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.
Other Information

Other information

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

Active ingredients (in each tablet)

Acetamionophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine Hydrochloride 5 mg

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)

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.

Allergy Sinus, Lil' Drug Store ®

[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]

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.

Structured Label Content

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
Purpose

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Warnings

​Warnings

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

Do Not Use (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.
Drug Facts

​Drug Facts

Ask A Doctor (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
Allergy Alert (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.

Liver Warning (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.
Other Information (Other information)

Other information

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

Active ingredients (in each tablet)

Acetamionophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine Hydrochloride 5 mg

Inactive Ingredients (Inactive ingredients)

Inactive ingredients

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

Questions Or Comments? (Questions or comments?)

Questions or comments?

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

When Using This Product (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)

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)

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

Keep Out of Reach of Children (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.

Allergy Sinus, Lil' Drug Store ®

[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]

Ask A Doctor Before Use If You Are (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.

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Raw Label Data

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