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Name:Bp8 Cough
Manufacturer:Macoven Pharmaceuticals
Category:Over-the-counter (OTC) Marketed Drugs


BP 8 Cough

BP8 COUGH - pseudoephedrine hydrochloride, guaifenesin and dextromethorphan hydrobromide liquid 
Macoven Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BP 8 Cough

Drug Facts

Active ingredients (in each 5 mL) Purpose
Dextromethorphan HBr 15 mg Cough Suppressant
Pseudoephedrine HCl 30 mg Decongestant
Guaifenesin 175 mg Expectorant

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the impulse to cough to help you get to sleep
    • nasal congestion due to the common cold
  • promotes nasal and/or sinus drainage

Warnings

  • may cause excitability, or increased irritability especially in children

  • 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.

Ask a doctor before use if you have

  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)
  • trouble with urination due to enlargement of the prostate gland

Stop Use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occurs
  • symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

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. 800-222-1222

Directions

  • take every 8 hours
  • do not take more than 3 doses in 24 hours or as directed by a doctor
Adults and children 12 years of age and older 2 teaspoonsful
Children 6 to under 12 years of age 1 teaspoonful
Children under 6 years of age Ask a doctor

Other Information

store at controlled room temperature 20°-25°C (68°-77°F)

  • Tamper Evident: Do not use if seal is broken or missing.

Inactive ingredients

Bitter Mask, Citric Acid, Glycerin, FD&C Blue #1, FD&C Red #40, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol

Questions?

Call 1-877-622-6836

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 44183-203-16

BP 8 Cough

No Antihistamine • Alcohol Free

Expectorant, Decongestant, Cough Suppressant

GRAPE FLAVOR

Each 5 mL (one teaspoonful) for oral administration
contains:
Dextromethorphan Hydrobromide 15 mg
Pseudoephedrine Hydrochloride 30 mg
Guaifenesin 175 mg

16 fl. oz. (473 mL)

MANUFACTURED FOR:
MACOVEN
PHARMACEUTICALS
Magnolia, TX 77354
Rev. 03/11

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

BP8 COUGH 
pseudoephedrine hydrochloride, guaifenesin, and dextromethorphan hydrobromide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:44183-203
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 175 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
GLYCERIN  
FD&C BLUE NO. 1  
FD&C RED NO. 40  
GRAPE  
PROPYLENE GLYCOL  
WATER  
SODIUM CITRATE  
SACCHARIN SODIUM  
SORBITOL  
Product Characteristics
Color PURPLE Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44183-203-16 473 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 03/24/2011

Labeler - Macoven Pharmaceuticals (832591965)

Revised: 03/2011 Macoven Pharmaceuticals



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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