Altipres Pediatric Liquid
FDA Label NDC 45737-105

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Generic Corporation for the product Altipres Pediatric (NDC 45737-105). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Inactive Ingredient

→ Otc - Questions

→ Package Label.principal Display Panel

Otc - Active Ingredient

Active Ingredients (in each 5 mL tsp.) Purpose

Dextromethorphan HBr ............... 5 mg ................ Cough Suppressant

Guaifenesin .............................. 75 mg ................ Expectorant

Phenylephrine HCl ..................... 2.5 mg ................... Nasal Decongestant

Otc - Purpose

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Indications & Usage

Uses

temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
temporarily releives nasal congestion due to the common cold.

Warnings

Do not use in a child who is 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 child's prescription drug contains an MAOI; ask your doctor or pharmacist before taking this product.

Ask a doctor before use if your child has

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to enlargement of prostate gland
a cough that occurs with too much phlegm (mucus)
cough that lasts or is chrinic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

your child gets 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 with a fever, rash or persistent headache. These could be signs of serious condition.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

Directions Do not exceed more than 6 doses in any 24-hour period.

Age	Dose
Adults and children 12 years of age and over	take 4 teaspoonfuls (20 mL) every 4 hours
Children 6 to under 12 years of age	take 2 teaspoonfuls (10 mL) every 4 hours
Children 2 to under 6 years of age	take 1 teaspoonfuls (5 mL) every 4 hours
Children under 2 years of age	do not use

Inactive Ingredient

Inactive ingredients:Citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

Otc - Questions

Questions or comments?1-305-403-3788

Package Label.Principal Display Panel

Altipres (Altipres)

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