COUGH AND COLD HBP- chlorpheniramine maleate, dextromethorphan hbr tablet, sugar coated 
L.N.K. International, Inc.

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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Quality Plus 44-411-Delisted

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg
Dextromethorphan HBr 30 mg

Purpose

Antihistamine
Cough suppressant

Uses

  • 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

Warnings

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

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • cough that occurs with excessive phlegm (mucus)
  • a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

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.

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.

Directions

  • 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 stearate, methylparaben, microcrystalline cellulose, povidone, propylene glycol, propylparaben, shellac, silica gel, sodium benzoate, stearic acid, sugar, talc, titanium dioxide

Questions or comments?

Call 1-800-426-9391

Principal Display Panel

QUALITY PLUS

NDC 50844-411-21

*Compare to the active ingredients
in Coricidin® HBP Cough & Cold

Cough &
Cold HBP

Cough suppressant - Dextromethorphan HBr
Antihistamine - Chlorpheniramine maleate

For People with High Blood Pressure

Relieves:
• Cough  • Runny Nose  • Sneezing
Decongestant-free

16 TABLETS

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc., owner of the registered trademark Coricidin® HBP
Cough & Cold.      50844    REV0512A41121

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA

Quality Plus 44-411

Quality Plus 44-411

COUGH AND COLD HBP 
chlorpheniramine maleate, dextromethorphan hbr tablet, sugar coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-411
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize9mm
FlavorImprint Code 411
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50844-411-212 in 1 CARTON05/03/200301/16/2020
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/03/200301/16/2020
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(50844-411)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(50844-411)

Revised: 3/2018
Document Id: 64efd360-f5a5-4713-a979-2f08ca5ba691
Set id: 924ae365-6b7d-4b92-b920-9d23a2a708bf
Version: 5
Effective Time: 20180306
 
L.N.K. International, Inc.