dimetapp cold and cough and nighttime cold and cough

dimetapp cold and cough and nighttime cold and cough
SPL v1
SPL
SPL Set ID 179259a9-231e-df03-e063-6294a90a145e
Route
oral
Published
Effective Date 2024-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (12.5 mg) brompheniramine (2 mg) dextromethorphan (10 mg)
Inactive Ingredients
anhydrous citric acid fd&c blue no. 1 fd&c red no. 40 glycerin propyl gallate propylene glycol water sodium benzoate sodium citrate, unspecified form sorbitol sucralose

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
otc monograph drug active Since 2024-06-01

Description

Dimetapp ® Nighttime Cold and Cough Drug Facts


Medication Information

Uses
  • temporarily relieves:
    • cough
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever (or other respiratory allergies)
  • relieves the impluse to cough to help you sleep
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

Description

Dimetapp ® Nighttime Cold and Cough Drug Facts

Section 42229-5

Dimetapp ®

Nighttime Cold and Cough

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1
Active ingredient (in each 10 mL) Purpose
Diphenhydramine HCl, 12.5 mg Antihistamine/cough suppressant
Do Not Use
  • to sedate a child or to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Questions Or Comments?

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

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.

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
Principal Display Panel Kit Carton

COLD & COUGH

NEW FORMULAS

CHILDREN'S

Dimetapp ®

Cold &

Cough

BROMPHENIRAMINE MALEATE (Antihistamine)

DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves + comforts:

  • Runny nose
  • Itchy, watery eyes
  • Sneezing
  • Cough

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:

  • Runny nose
  • Itchy, watery eyes
  • Sneezing
  • Cough

PHARMACIST

RECOMMENDED

6+

YRS

Grape Flavor

Alcohol Free

1 BOTTLE

4 FL OZ (118 mL)

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers


Structured Label Content

Uses
  • temporarily relieves:
    • cough
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever (or other respiratory allergies)
  • relieves the impluse to cough to help you sleep
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 (Other information)
  • each 10 mL contains: sodium 8 mg
  • store at 20-25°C (68-77°F)
  • do not refrigerate
Inactive Ingredients (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

Section 42229-5 (42229-5)

Dimetapp ®

Nighttime Cold and Cough

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredient (in each 10 mL) Purpose
Diphenhydramine HCl, 12.5 mg Antihistamine/cough suppressant
Do Not Use (Do not use)
  • to sedate a child or to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Questions Or Comments? (Questions or comments?)

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

When Using This Product (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 (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.

Ask A Doctor Before Use If You Have (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
Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

COLD & COUGH

NEW FORMULAS

CHILDREN'S

Dimetapp ®

Cold &

Cough

BROMPHENIRAMINE MALEATE (Antihistamine)

DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves + comforts:

  • Runny nose
  • Itchy, watery eyes
  • Sneezing
  • Cough

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:

  • Runny nose
  • Itchy, watery eyes
  • Sneezing
  • Cough

PHARMACIST

RECOMMENDED

6+

YRS

Grape Flavor

Alcohol Free

1 BOTTLE

4 FL OZ (118 mL)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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