Dimetapp®
Cold and Cough

Drug Facts

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

Dimetapp®
Nighttime Cold and Congestion

Drug Facts

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

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

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

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

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

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

Labeler - Foundation Consumer Brands (117603632)

Dimetapp® Cold and Cough and Dimetapp® Nighttime Cold and Congestion

Uses

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions or comments?

Uses

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions or comments?

PRINCIPAL DISPLAY PANEL - Kit Carton