Dimetapp Cold And Cough And Dimetapp Nighttime Cold And Cough

Dimetapp Cold And Cough And Dimetapp Nighttime Cold And Cough
SPL v1
SPL
SPL Set ID 1820e7c7-bc11-9061-e063-6394a90ae581
Route
ORAL
Published
Effective Date 2021-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Brompheniramine (2 mg) Dextromethorphan (10 mg) Diphenhydramine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose Propyl Gallate

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-01

Description

Dimetapp ® Cold and Cough Drug Facts


Medication Information

Description

Dimetapp ® Cold and Cough Drug Facts

Uses
  • temporarily relieves:
    • cough
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever
  • temporarily alleviates the intensity of coughing
Section 42229-5

Dimetapp ®

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 ingredients (in each 10 mL) Purposes
Brompheniramine maleate, 2 mg Antihistamine
Dextromethorphan HBr, 10 mg Cough suppressant
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
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.
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

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

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

NIGHTTIME

VALUE PACK

New Formulas

CHILDREN'S

Dimetapp®

Cold & Cough

BROMPHENIRAMINE MALEATE (Antihistamine)

DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves + comforts:

Runny nose

Itchy, watery eyes

Sneezing

Cough

Grape Flavor

Alcohol Free

6+

YRS

2 BOTTLES

4 FL OZ (118 mL) EACH

Nighttime

Cold &

Cough

DIPHENHYDRAMINE HCl

(Antihistamine/Cough Suppressant)

Relieves + comforts:

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

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
  • temporarily alleviates the intensity of coughing
Section 42229-5 (42229-5)

Dimetapp ®

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 ingredients (in each 10 mL) Purposes
Brompheniramine maleate, 2 mg Antihistamine
Dextromethorphan HBr, 10 mg Cough suppressant
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
Do Not Use (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.
Other Information (Other information)
  • each 10 mL contains: sodium 6 mg
  • store at 20-25°C (68-77°F)
Inactive Ingredients (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? (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 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 (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

NIGHTTIME

VALUE PACK

New Formulas

CHILDREN'S

Dimetapp®

Cold & Cough

BROMPHENIRAMINE MALEATE (Antihistamine)

DEXTROMETHORPHAN HBr (Cough Suppressant)

Relieves + comforts:

Runny nose

Itchy, watery eyes

Sneezing

Cough

Grape Flavor

Alcohol Free

6+

YRS

2 BOTTLES

4 FL OZ (118 mL) EACH

Nighttime

Cold &

Cough

DIPHENHYDRAMINE HCl

(Antihistamine/Cough Suppressant)

Relieves + comforts:

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

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

All Sections (JSON)