Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f
Route
ORAL
Published
Effective Date 2018-12-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Phenylephrine (5 mg)
Inactive Ingredients
Starch, Corn Fd&c Yellow No. 6 Hypromelloses Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Stearic Acid Titanium Dioxide Crospovidone

Identifiers & Packaging

Pill Appearance
Imprint: AZ270 Shape: capsule Color: orange Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2014-12-22 Until 2027-10-31

Description

Acetaminophen 325 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Nasal decongestant

Description

Acetaminophen 325 mg Phenylephrine HCl 5 mg

Uses

temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:  

  • sinus congestion and pressure
  • headache
  • minor aches and pains
  • nasal congestion
  • promotes sinus drainage
  • temporarily reduces fever
Directions

do not use more than directed (see overdose warning)

adults and children 12 years of age and older:

  • take 2 caplets every 4-6 hours
  • do not take more than 10 caplets in 24 hours  

children under 12 years:

  • ask a doctor 
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 using this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients  
Inactive Ingredients

corn starch, crospovidone, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

When Using This Product

When using this product do not exceed recommended dose

Liver Warning/allergy Alert

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take

  • more than 4,000mg of acetaminophen in 24 hours
  • with other drugs containing acetminophen
  • 3 or more alcoholic drinks every day while using this product

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.

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
  • You may report side effects to 1-888-952-0050
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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Caplet)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate
Package/label Principal Display Panel
Sinus Headache
Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin


Structured Label Content

Uses

temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:  

  • sinus congestion and pressure
  • headache
  • minor aches and pains
  • nasal congestion
  • promotes sinus drainage
  • temporarily reduces fever
Purpose

Pain reliever/fever reducer

Nasal decongestant

Directions

do not use more than directed (see overdose warning)

adults and children 12 years of age and older:

  • take 2 caplets every 4-6 hours
  • do not take more than 10 caplets in 24 hours  

children under 12 years:

  • 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 using this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients  
Inactive Ingredients

corn starch, crospovidone, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

When Using This Product (When using this product)

When using this product do not exceed recommended dose

Liver Warning/allergy Alert (Liver warning/Allergy alert)

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take

  • more than 4,000mg of acetaminophen in 24 hours
  • with other drugs containing acetminophen
  • 3 or more alcoholic drinks every day while using this product

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.

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
  • You may report side effects to 1-888-952-0050
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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate
Package/label Principal Display Panel (Package/Label Principal Display Panel)
Sinus Headache
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

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