alt-altipresped 105

alt-altipresped 105
SPL v3
SPL
SPL Set ID 2a336896-a2f8-2a0c-e063-6294a90ae03a
Route
oral
Published
Effective Date 2025-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (5 mg) guaifenesin (75 mg) phenylephrine (2.5 mg)
Inactive Ingredients
sucralose citric acid monohydrate methylparaben glycerin propylparaben water sodium citrate propylene glycol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-12-01
Description

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

Medication Information

Warnings and Precautions

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.
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

Indications and 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.
Dosage and 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

Description

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

Section 50565-1

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

Section 51727-6

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

Section 51945-4

Section 53413-1

Questions or comments?1-305-403-3788

Section 53414-9

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

Section 55105-1

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Structured Label Content

Warnings and Precautions (34071-1)

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.
Active Ingredient (55106-9)

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

Indications and Usage (34067-9)

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.
Dosage and Administration (34068-7)

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

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?1-305-403-3788

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:56.462402 · Updated: 2026-03-14T23:11:59.437858