acetaminophen, dextromethorphan and phenylephrine day time cold and flu

acetaminophen, dextromethorphan and phenylephrine day time cold and flu
SPL v3
SPL
SPL Set ID 563452d1-0c19-4094-895a-805c859bc49b
Route
oral
Published
Effective Date 2012-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (325 mg) dextromethorphan (10 mg) phenylephrine (5 mg)
Inactive Ingredients
fd&c red no. 40 fd&c yellow no. 6 gelatin polyethylene glycol 1000 povidone propylene glycol sorbitol titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 512 Shape: capsule Color: orange Size: 22 mm Score: 1
Marketing Status
otc monograph final active Since 2014-05-01

Purpose

pain reliever Cough Suppressant Nasal decongestant

Description

(in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg


Medication Information

Warnings

Warnings Failure to follow these warnings could result in serious consequences.

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

  • more than 4 doses in 24 hours which is maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

do not use:

  • with any other drug containing acetaminophen (prescription or not prescription). 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 before use if you have

  • liver disease
  • Heart disease
  • Thyroid disease
  • Diabetes
  • High blood pressure
  • Trouble urinating due to enlarged prostate gland
  • ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed.

  • Stop use and ask a doctor if:

  • Redness or swelling is present
  • You get nervous, dizzy or sleepless
  • Fever gets worse or lasts more than 3 days
  • New symptoms occur
  • Symptoms do not get better within 7 days or are accompanied by a fever
Uses

pain reliever, cough suppressant and Nasal decongestant

Purpose

pain reliever

Cough Suppressant

Nasal decongestant

Other Information
  • store at room temperature
Inactive Ingredients

FD&C Red No.40, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide

Description

(in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Direction
  • do not exceed 4 doses per 24 hours
  • take only as directed – see overdose warning
  • Adults and children 12 years and over: 2 softgels with water every 4 hours
  • children under 12 years: ask a doctor
  • Children under 4 years: do not use
Active Ingredient

(in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Questions Or Comments

Call toll free 1-855-314-1850

Keep Out of Reach of Children.

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

Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. 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.

Tamper evident: this package is safety sealed and child resistant. Use only if blisters are intact. If difficult to open use scissors.

Package Label.principal Display Panel

NDC: 58805-002-14  , 58805-002-08


Structured Label Content

Warnings

Warnings Failure to follow these warnings could result in serious consequences.

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

  • more than 4 doses in 24 hours which is maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

do not use:

  • with any other drug containing acetaminophen (prescription or not prescription). 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 before use if you have

  • liver disease
  • Heart disease
  • Thyroid disease
  • Diabetes
  • High blood pressure
  • Trouble urinating due to enlarged prostate gland
  • ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed.

  • Stop use and ask a doctor if:

  • Redness or swelling is present
  • You get nervous, dizzy or sleepless
  • Fever gets worse or lasts more than 3 days
  • New symptoms occur
  • Symptoms do not get better within 7 days or are accompanied by a fever
Uses

pain reliever, cough suppressant and Nasal decongestant

Purpose

pain reliever

Cough Suppressant

Nasal decongestant

Other Information
  • store at room temperature
Inactive Ingredients

FD&C Red No.40, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide

Direction
  • do not exceed 4 doses per 24 hours
  • take only as directed – see overdose warning
  • Adults and children 12 years and over: 2 softgels with water every 4 hours
  • children under 12 years: ask a doctor
  • Children under 4 years: do not use
Active Ingredient

(in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Questions Or Comments (Questions or Comments)

Call toll free 1-855-314-1850

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. 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.

Tamper evident: this package is safety sealed and child resistant. Use only if blisters are intact. If difficult to open use scissors.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC: 58805-002-14  , 58805-002-08


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)