Label: COUGH AND COLD- chlorpheniramine maleate and dextromethorphan hydrobromide tablet
- NDC Code(s): 59779-411-21
- Packager: WOONSOCKET PRESCRIPTION CENTER,INCORPORATED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active ingredients (in each tablet)
Chlorpheniramine maleate 4 mgClose
Dextromethorphan HBr 30 mg
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- temporarily relieves runny nose and sneezing due to the common cold
Do not use
if you are 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
- trouble urinating due to an enlarged prostate gland
- cough that occurs with excessive phlegm (mucus)
- a breathing problem or presistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
When using this product
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
cough lasts more than 7 days, reoccurs, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.
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.
- do not exceed recommended dose
- adults and children 12 years and over: 1 tablet every 6 hours. Do not take more than 4 tablets in 24 hours
- children under 12 years: do not use
- Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
- Inactive ingredients
acacia, black iron oxide, calcium carbonate, carnauba wax, croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, lactose, magnesium searate, methylparaben, microcrystalline cellulose, povidone, propylene glycol, propylparaben, shellac, silica gel, sodium benzoate, stearic acid, sugar, talc, titanium dioxideClose
- Questions or comments?
- Principal Display Panel
Compare to the active ingredients in Coricidin® HBP Cough & Cold*
& COLD BP
ANTIHISTAMINE - CHLORPHENIRAMINE MALEATE
COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr
• Runny Nose
FOR PEOPLE WITH HIGH BLOOD PRESSURE
*This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc., owner of the registered trademark Coricidin® HBP Cough & Cold.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2011 CVS/pharmacy
CVS HBP 44-411
- INGREDIENTS AND APPEARANCE
COUGH AND COLD
chlorpheniramine maleate and dextromethorphan hbr tablet
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-411 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 4 mg DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 30 mg Inactive Ingredients Ingredient Name Strength ACACIA CALCIUM CARBONATE CARNAUBA WAX CROSCARMELLOSE SODIUM D&C RED NO. 27 LACTOSE MAGNESIUM STEARATE METHYLPARABEN CELLULOSE, MICROCRYSTALLINE POVIDONES PROPYLPARABEN PROPYLENE GLYCOL SHELLAC SODIUM BENZOATE STEARIC ACID TALC TITANIUM DIOXIDE Product Characteristics Color RED Score no score Shape ROUND Size 11mm Flavor Imprint Code 411 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-411-21 2 in 1 CARTON 1 8 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 05/03/2003 Labeler - WOONSOCKET PRESCRIPTION CENTER,INCORPORATED (062312574) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(59779-411) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(59779-411)