Principal Display Panel

Principal Display Panel
SPL v3
SPL
SPL Set ID 8cea1101-e91e-41ab-9fb5-da6ab61ea34f
Route
ORAL
Published
Effective Date 2021-01-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Brompheniramine maleate, USP 2 mg Dextromethorphan HBr, USP 10 mg Phenylephrine HCl, USP 5 mg


Medication Information

Indications and Usage

• temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies • 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

• 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

Description

Brompheniramine maleate, USP 2 mg Dextromethorphan HBr, USP 10 mg Phenylephrine HCl, USP 5 mg

Section 44425-7

• each 10 mL contains: sodium 4 mg • store at 20°-25°C (68°-77°F)

Section 50565-1

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9

• you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days or are accompanied by fever • cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

Section 50567-7

• 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

Section 50568-5

taking sedatives or tranquilizers

Section 50569-3

• 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 such as emphysema or chronic bronchitis • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Section 50570-1

• 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. • to make a child sleepy

Section 51727-6

anhydrous citric acid, edetate disodium, FD & C blue no. 1, FD & C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution

Section 51945-4

For Ages 6 & Older Compare to Children’s Dimetapp ® Cold & Cough active ingredients Children’s Cold & Cough Brompheniramine Maleate (Antihistamine) Dextromethorphan HBr (Cough Suppressant) Phenylephrine HCl (Nasal Decongestant) Relieves Nasal Symptoms Stuffy Nose, Runny Nose, Sneezing Plus Other Symptoms Itchy, Watery Eyes; Cough Alcohol-Free Grape Flavor Dosage Cup Included 8 FL OZ (237 mL)

Section 53413-1

1-800-719-9260

Section 53414-9

ask a health professional before use.

Section 55105-1

Antihistamine Cough suppressant Nasal decongestant

Section 55106-9

Brompheniramine maleate, USP 2 mg Dextromethorphan HBr, USP 10 mg Phenylephrine HCl, USP 5 mg


Structured Label Content

Indications and Usage (34067-9)

• temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies • 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)

• 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

Section 44425-7 (44425-7)

• each 10 mL contains: sodium 4 mg • store at 20°-25°C (68°-77°F)

Section 50565-1 (50565-1)

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9 (50566-9)

• you get nervous, dizzy, or sleepless • symptoms do not get better within 7 days or are accompanied by fever • cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

Section 50567-7 (50567-7)

• 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

Section 50568-5 (50568-5)

taking sedatives or tranquilizers

Section 50569-3 (50569-3)

• 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 such as emphysema or chronic bronchitis • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Section 50570-1 (50570-1)

• 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. • to make a child sleepy

Section 51727-6 (51727-6)

anhydrous citric acid, edetate disodium, FD & C blue no. 1, FD & C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution

Section 51945-4 (51945-4)

For Ages 6 & Older Compare to Children’s Dimetapp ® Cold & Cough active ingredients Children’s Cold & Cough Brompheniramine Maleate (Antihistamine) Dextromethorphan HBr (Cough Suppressant) Phenylephrine HCl (Nasal Decongestant) Relieves Nasal Symptoms Stuffy Nose, Runny Nose, Sneezing Plus Other Symptoms Itchy, Watery Eyes; Cough Alcohol-Free Grape Flavor Dosage Cup Included 8 FL OZ (237 mL)

Section 53413-1 (53413-1)

1-800-719-9260

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Antihistamine Cough suppressant Nasal decongestant

Section 55106-9 (55106-9)

Brompheniramine maleate, USP 2 mg Dextromethorphan HBr, USP 10 mg Phenylephrine HCl, USP 5 mg


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