Guaifenesin 400 Mg - Dextromethorphancaplets 20 Mg Caplets

Guaifenesin 400 Mg - Dextromethorphancaplets 20 Mg Caplets
SPL v101
SPL
SPL Set ID 8c25285e-e2cd-4e10-af63-5dce8098b615
Route
ORAL
Published
Effective Date 2024-10-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Magnesium Stearate Maltodextrin Povidone, Unspecified Silicon Dioxide Stearic Acid Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: AP;150 Shape: oval Color: white Size: 17 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-04-01

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Purpose

Cough suppressant Expectorant

How Supplied

Guaifenesin and Dextromethorphan HBr 400 mg/20 mg Tablets NDC: 71335-1928-1: 30 Tablets in a BOTTLE NDC: 71335-1928-2: 20 Tablets in a BOTTLE NDC: 71335-1928-3: 18 Tablets in a BOTTLE store at 15º-30ºC (59º-86ºF) Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504


Medication Information

Purpose

Cough suppressant

Expectorant

How Supplied

Guaifenesin and Dextromethorphan HBr 400 mg/20 mg Tablets

  • NDC: 71335-1928-1: 30 Tablets in a BOTTLE
  • NDC: 71335-1928-2: 20 Tablets in a BOTTLE
  • NDC: 71335-1928-3: 18 Tablets in a BOTTLE

store at 15º-30ºC (59º-86ºF)

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive 
Section 51945-4

Guaifenesin and Dextromethorphan HBr 400 mg/20 mg Tablets

Directions
  • take with a full glass of water
  • adults and children 12 years of age and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
  • children under 12 years: do not use
Do Not Use

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. 

Other Information
  • store at 15º-30ºC (59º-86ºF)
Inactive Ingredients

Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid

Questions Or Comments?

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

When Using This Product

do not use more than directed. 

Stop Use and Ask A Doctor If

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition. 

If Pregnant Or Breast Feeding,

 ask a health professional before use.

Keep Out of Reach of Children.

 In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each Caplet)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Ask A Doctor Before Use If You Have
  • cough accompanied by too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Structured Label Content

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive 
Section 51945-4 (51945-4)

Guaifenesin and Dextromethorphan HBr 400 mg/20 mg Tablets

Purpose

Cough suppressant

Expectorant

Directions
  • take with a full glass of water
  • adults and children 12 years of age and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
  • children under 12 years: do not use
Do Not Use (Do not use)

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. 

How Supplied (HOW SUPPLIED)

Guaifenesin and Dextromethorphan HBr 400 mg/20 mg Tablets

  • NDC: 71335-1928-1: 30 Tablets in a BOTTLE
  • NDC: 71335-1928-2: 20 Tablets in a BOTTLE
  • NDC: 71335-1928-3: 18 Tablets in a BOTTLE

store at 15º-30ºC (59º-86ºF)

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Other Information (Other information)
  • store at 15º-30ºC (59º-86ºF)
Inactive Ingredients (Inactive ingredients)

Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid

Questions Or Comments? (Questions or comments?)

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

When Using This Product (When using this product)

do not use more than directed. 

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. 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.

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • cough accompanied by too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Advanced Ingredient Data


Raw Label Data

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