Dimetapp ®

Dimetapp ®
SPL v6
SPL
SPL Set ID 4f7b773b-950f-41fb-b024-689a89019fda
Route
ORAL
Published
Effective Date 2021-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Brompheniramine (1 mg) Pseudoephedrine (15 mg)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Blue No. 1 Fd&c Red No. 40 High Fructose Corn Syrup Saccharin Sodium Sodium Benzoate Sorbitol Water

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
EXPORT ONLY Active Since 2015-07-09

Description

Active ingredients (in each 5 mL tsp) Purpose Brompheniramine maleate, USP 1 mg Antihistamine Pseudoephedrine HCl, USP 15 mg Nasal decongestant


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • temporarily relieves nasal and sinus congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis):
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily restores freer breathing through the nose
Dosage and Administration

Directions

  • do not take more than 4 doses in any 24-hour period
age dose

adults and children 12 years and over

4 tsp every 4 hours

children 6 to under 12 years

2 tsp every 4 hours

children under 6 years

Do not use

Description

Active ingredients (in each 5 mL tsp) Purpose Brompheniramine maleate, USP 1 mg Antihistamine Pseudoephedrine HCl, USP 15 mg Nasal decongestant

Section 44425-7

Other information

  • store at 20-25°C (68-77°F)
  • not a USP elixir
  • dosage cup provided
  • Pleasant tasting – children find its great grape taste easy to take.
  • Adults like it, too – especially those who have difficulty swallowing tablets or capsules.
Section 50565-1

Keep out of reach of children. In case of overdose, get medical help.

Section 50566-9

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days or are accompanied by fever
Section 50567-7

When using this product

  • do not use more than directed
  • drowsiness may occur
  • 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
Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 50569-3

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
  • a breathing problem such as emphysema or chronic bronchitis
Section 50570-1

Do not useif 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.

Section 51727-6

Inactive ingredients

artificial flavor, citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, high fructose corn syrup, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, purified water

Section 53414-9

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

Section 55105-1
Active ingredients (in each 5 mL tsp) Purpose

Brompheniramine maleate, USP 1 mg

Antihistamine

Pseudoephedrine HCl, USP 15 mg

Nasal decongestant

Principal Display Panel 118 Ml Bottle Carton

Dimetapp ®

Elixir

NASAL DECONGESTANT

ANTIHISTAMINE

GREAT GRAPE TASTE

FOR CHILDREN & ADULTS

RELIEVES COLD AND

ALLERGY SYMPTOMS

NASAL CONGESTION

RUNNING NOSE

ITCHY, WATERY EYES

SNEEZING

4 FL. OZ. (118 mL)


Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves nasal and sinus congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis):
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily restores freer breathing through the nose
Dosage and Administration (34068-7)

Directions

  • do not take more than 4 doses in any 24-hour period
age dose

adults and children 12 years and over

4 tsp every 4 hours

children 6 to under 12 years

2 tsp every 4 hours

children under 6 years

Do not use

Warnings and Precautions (34071-1)

Warnings

Section 44425-7 (44425-7)

Other information

  • store at 20-25°C (68-77°F)
  • not a USP elixir
  • dosage cup provided
  • Pleasant tasting – children find its great grape taste easy to take.
  • Adults like it, too – especially those who have difficulty swallowing tablets or capsules.
Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days or are accompanied by fever
Section 50567-7 (50567-7)

When using this product

  • do not use more than directed
  • drowsiness may occur
  • 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
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 50569-3 (50569-3)

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
  • a breathing problem such as emphysema or chronic bronchitis
Section 50570-1 (50570-1)

Do not useif 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.

Section 51727-6 (51727-6)

Inactive ingredients

artificial flavor, citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, high fructose corn syrup, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, purified water

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 5 mL tsp) Purpose

Brompheniramine maleate, USP 1 mg

Antihistamine

Pseudoephedrine HCl, USP 15 mg

Nasal decongestant

Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton)

Dimetapp ®

Elixir

NASAL DECONGESTANT

ANTIHISTAMINE

GREAT GRAPE TASTE

FOR CHILDREN & ADULTS

RELIEVES COLD AND

ALLERGY SYMPTOMS

NASAL CONGESTION

RUNNING NOSE

ITCHY, WATERY EYES

SNEEZING

4 FL. OZ. (118 mL)


Advanced Ingredient Data


Raw Label Data

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