DIMETAPP COLD AND COUGH AND DIMETAPP NIGHTTIME COLD AND CONGESTION- brompheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride, and diphenhydramine hyrdochloride kit

Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestion by

Drug Labeling and Warnings

Dimetapp Cold and Cough and Dimetapp Nighttime Cold and Congestion by is a Otc medication manufactured, distributed, or labeled by Foundation Consumer Brands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Dimetapp®
Cold and Cough

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 10 mL)	Purposes
Brompheniramine maleate, 2 mg	Antihistamine
Dextromethorphan HBr, 10 mg	Cough suppressant
Phenylephrine HCl, 5 mg	Nasal decongestant

Uses

• temporarily relieves:
  • nasal congestion
  • runny nose
  • cough
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever
• temporarily restores freer breathing through the nose

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

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• 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 any other oral nasal decongestant or stimulant
• taking sedatives or tranquilizers

When using this product

• do not use more than directed
• may cause marked drowsiness
• avoid alcoholic beverages
• 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

• nervousness, dizziness or sleeplessness occurs
• symptoms do not get better within 7 days or are accompanied by fever
• 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

• do not take more than 6 doses in any 24-hour period
• measure only with dosage cup provided
• keep dosage cup with product
• mL = milliliter

age	dose
adults and children 12 years and over	20 mL every 4 hours
children 6 to under 12 years	10 mL every 4 hours
children under 6 years	do not use

Other information

• each 10 mL contains: sodium 6 mg
• store at 20-25°C (68-77°F)

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

SPL UNCLASSIFIED SECTION

Dimetapp®
Nighttime Cold and Congestion

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 10 mL)	Purposes
Diphenhydramine HCl, 12.5 mg	Antihistamine/cough suppressant
Phenylephrine HCl, 5 mg	Nasal decongestant

Uses

• temporarily relieves:
  • nasal congestion
  • runny nose
  • cough
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever
• temporarily restores freer breathing through the nose

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.
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• 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 or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

• taking any other oral nasal decongestant or stimulant
• 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

• nervousness, dizziness or sleeplessness occurs
• symptoms do not get better within 7 days or are accompanied by fever
• 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

• do not take more than 6 doses in any 24-hour period
• measure only with dosage cup provided
• keep dosage cup with product
• mL = milliliter

age	dose
adults and children 12 years and over	20 mL every 4 hours
children 6 to under 12 years	10 mL every 4 hours
children under 6 years	do not use

Other information

• each 10 mL contains: sodium 8 mg
• store at 20-25°C (68-77°F)
• do not refrigerate

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - Kit Carton

DAYTIME
NIGHTTIME

CHILDREN'S
Dimetapp®

Cold & Cough

BROMPHENIRAMINE MALEATE (Antihistamine)
DEXTROMETHORPHAN HBr (Cough Suppressant)
PHENYLEPHRINE HCl (Nasal Decongestant)

Relieves + comforts:

• ✔ Stuffy, runny nose
• ✔ Itchy, watery eyes
• ✔ Sneezing
• ✔ Cough

Grape Flavor
Alcohol Free

6+
YRS

2 BOTTLES

PHARMACIST
RECOMMENDED

4 FL OZ (118 mL) EACH

Nighttime
Cold &
Congestion

DIPHENHYDRAMINE HCl
(Antihistamine/Cough Suppressant)
PHENYLEPHRINE HCl
(Nasal Decongestant)

Relieves + comforts:

• ✔ Stuffy, runny nose
• ✔ Itchy, watery eyes
• ✔ Sneezing
• ✔ Cough

6+
YRS

Grape Flavor
Alcohol Free

1 BOTTLE

4 FL OZ (118 mL)

12 FL OZ (354 mL) TOTAL

INGREDIENTS AND APPEARANCE

DIMETAPP COLD AND COUGH AND DIMETAPP NIGHTTIME COLD AND CONGESTION 
brompheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride, and diphenhydramine hyrdochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80070-360

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80070-360-12	1 in 1 CARTON	09/15/2021

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 BOTTLE	236 mL
Part 2	1 BOTTLE	118 mL

Part 1 of 2

DIMETAPP   COLD AND COUGH
brompheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride elixir

Product Information
Item Code (Source)	NDC: 80070-310
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)	BROMPHENIRAMINE MALEATE	1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80070-310-04	1 in 1 CARTON
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M012	09/15/2021

Part 2 of 2

DIMETAPP   NIGHTTIME COLD AND CONGESTION
diphenhydramine hydrochloride and phenylephrine hydrochloride solution

Product Information
Item Code (Source)	NDC: 80070-340
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	6.25 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80070-340-04	1 in 1 CARTON
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M012	09/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M012	09/15/2021

Labeler - Foundation Consumer Brands (117603632)