DIMETAPP COLD AND COUGH AND NIGHTTIME COLD AND COUGH- diphenhydramine hydrochloride, brompheniramine maleate, and dextromethorphan hydrobromide 
Foundation Consumer Healthcare

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Dimetapp Cold and Cough and Nighttime Cold and Cough

Dimetapp ®
Nighttime Cold and Cough

Drug Facts

Active ingredient (in each 10 mL)Purpose
Diphenhydramine HCl, 12.5 mgAntihistamine/cough suppressant

Uses

Warnings

Do not use

  • to sedate a child or to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts such 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

  • do not use more than directed
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or is accompanied by 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

agedose
adults and children 12 years and over20 mL every 4 hours
children 6 to under 12 years10 mL every 4 hours
children under 6 yearsdo not use

Other information

Inactive ingredients

anhydrous citric acid, artificial flavor, FD&C blue no.1, FD&C red no. 40, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments?

Call 1-888-594-0828 weekdays 9 AM to 5 PM EST

Dimetapp ®
Cold and Cough

Drug Facts

Active ingredients (in each 10 mL)Purposes
Brompheniramine maleate, 2 mgAntihistamine
Dextromethorphan HBr, 10 mgCough suppressant

Uses

Warnings

Do not use

  • to sedate a child or to make a child sleepy
  • 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 too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts such 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

  • do not use more than directed
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or is accompanied by 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

agedose
adults and children 12 years and over20 mL every 4 hours
children 6 to under 12 years10 mL every 4 hours
children under 6 yearsdo not use

Other information

Inactive ingredients

anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments?

Call 1-888-594-0828 weekdays 9 AM to 5 PM EST

Distributed by:
Foundation Consumer Healthcare, LLC, Pittsburgh, PA 15212

PRINCIPAL DISPLAY PANEL - Kit Carton

COLD & COUGH

NEW FORMULAS

CHILDREN'S
Dimetapp ®

Cold &
Cough

BROMPHENIRAMINE MALEATE (Antihistamine)
DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves + comforts:

6+
YRS

Grape Flavor
Alcohol Free

1 BOTTLE

4 FL OZ (118 mL)

8 FL OZ (236 mL) TOTAL

NIGHTTIME

Nighttime
Cold &
Cough

DIPHENHYDRAMINE HCl (Antihistamine/
Cough Suppressant)

Relieves + comforts:

PHARMACIST
RECOMMENDED

6+
YRS

Grape Flavor
Alcohol Free

1 BOTTLE

4 FL OZ (118 mL)

Dimetapp 8oz Carton

DIMETAPP  COLD AND COUGH AND NIGHTTIME COLD AND COUGH
diphenhydramine hydrochloride, brompheniramine maleate, and dextromethorphan hydrobromide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69536-355
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69536-355-081 in 1 CARTON06/01/2024
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 118 mL
Part 21 BOTTLE 118 mL
Part 1 of 2
DIMETAPP  NIGHTTIME COLD AND COUGH
diphenhydramine hydrochloride solution
Product Information
Item Code (Source)NDC:69536-345
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorpurpleScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69536-345-041 in 1 CARTON
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/01/2024
Part 2 of 2
DIMETAPP  COLD AND COUGH
brompheniramine maleate, dextromethorphan hydrobromide solution
Product Information
Item Code (Source)NDC:69536-315
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE2 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorpurpleScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69536-315-041 in 1 CARTON
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/01/2024
Labeler - Foundation Consumer Healthcare (079675882)

Revised: 6/2024
Document Id: 17925cc1-55d4-5673-e063-6394a90aabcb
Set id: 179259a9-231e-df03-e063-6294a90a145e
Version: 1
Effective Time: 20240601
 
Foundation Consumer Healthcare