Curahist Dm

Curahist Dm
SPL v3
SPL
SPL Set ID 1019d607-dbd1-5fa0-e063-6394a90aa4d4
Route
ORAL
Published
Effective Date 2024-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (7.5 mg) Pyrilamine
Inactive Ingredients
Anhydrous Citric Acid Sorbitol Propylene Glycol Propylparaben Water Sucralose Methylparaben Potassium Sorbate Ammonium Glycyrrhizate Potassium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-15

Description

Directions: Do not exceed the recommended dosage. Adults and children 12 years of age and over - 4 teaspoonfuls every 6-8 hours, not To exceed 16 teaspoonfuls in 24 hours, or as directed by a doctor Children 6 years to under12 years of age - 2 teaspoonfuls every 6-8 hours, not to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor Children under 6 years of age - consult a doctor


Medication Information

Warnings and Precautions

Warnings

Do not exceed recommended dosage.

■ a persistent cough may be a sign of a serious condition.

If cough persist for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.

Do not use this product

■ if you are now taking a prescription monoamine oxidase inhibitor (MADI)(certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MADI drug. If you do not know if your prescription drug contains an MADI, ask a doctor or pharmacist before taking this product

■ for persistent or chronic cough such as occurs with

smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm(mucus) unless directed by a doctor

Ask a doctor before use if you have

■ a breathing problem such as emphysema or chronic bronchitis ■glaucoma ■difficulty in urination due to enlargement of the prostate gland

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

When using this product

■ excitability may occur, especially in children ■may cause marked drowsiness ■ sedatives and tranquilizers may increase drowsiness effect ■avoid alcoholic beverages ■ use caution when driving a motor vehicle or operating machinery

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

Indications and Usage

Uses temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

■ runny nose ■sneezing ■itching of the nose or throat

■ itchy, watery eyes ■cough due to minor throat and bronchial irritation associated with a cold ■alleviates cough to help you sleep ■nonnarcotic cough suppressant for the relief of cough

Dosage and Administration

Directions: Do not exceed the recommended dosage.

Adults and children 12 years of age and over - 4 teaspoonfuls every 6-8 hours, not

To exceed 16 teaspoonfuls in 24 hours, or as directed by a doctor

Children 6 years to under12 years of age - 2 teaspoonfuls every 6-8 hours, not

to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor

Children under 6 years of age - consult a doctor

Description

Directions: Do not exceed the recommended dosage. Adults and children 12 years of age and over - 4 teaspoonfuls every 6-8 hours, not To exceed 16 teaspoonfuls in 24 hours, or as directed by a doctor Children 6 years to under12 years of age - 2 teaspoonfuls every 6-8 hours, not to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor Children under 6 years of age - consult a doctor

Section 50565-1

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Section 51727-6

Inactive ingredients: Citric acid, flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sorbitol, sucralose

Section 51945-4

Section 55105-1

Antitussive/Antihistamine

Section 55106-9

Active Ingredients (in each 5 ml teaspoonful)

Dextromethorphan HBr 7.5mg

Pyrilamine Maleate 7.5mg


Structured Label Content

Indications and Usage (34067-9)

Uses temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

■ runny nose ■sneezing ■itching of the nose or throat

■ itchy, watery eyes ■cough due to minor throat and bronchial irritation associated with a cold ■alleviates cough to help you sleep ■nonnarcotic cough suppressant for the relief of cough

Dosage and Administration (34068-7)

Directions: Do not exceed the recommended dosage.

Adults and children 12 years of age and over - 4 teaspoonfuls every 6-8 hours, not

To exceed 16 teaspoonfuls in 24 hours, or as directed by a doctor

Children 6 years to under12 years of age - 2 teaspoonfuls every 6-8 hours, not

to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor

Children under 6 years of age - consult a doctor

Warnings and Precautions (34071-1)

Warnings

Do not exceed recommended dosage.

■ a persistent cough may be a sign of a serious condition.

If cough persist for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.

Do not use this product

■ if you are now taking a prescription monoamine oxidase inhibitor (MADI)(certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MADI drug. If you do not know if your prescription drug contains an MADI, ask a doctor or pharmacist before taking this product

■ for persistent or chronic cough such as occurs with

smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm(mucus) unless directed by a doctor

Ask a doctor before use if you have

■ a breathing problem such as emphysema or chronic bronchitis ■glaucoma ■difficulty in urination due to enlargement of the prostate gland

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

When using this product

■ excitability may occur, especially in children ■may cause marked drowsiness ■ sedatives and tranquilizers may increase drowsiness effect ■avoid alcoholic beverages ■ use caution when driving a motor vehicle or operating machinery

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

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

Inactive ingredients: Citric acid, flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sorbitol, sucralose

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antitussive/Antihistamine

Section 55106-9 (55106-9)

Active Ingredients (in each 5 ml teaspoonful)

Dextromethorphan HBr 7.5mg

Pyrilamine Maleate 7.5mg


Advanced Ingredient Data


Raw Label Data

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