Alt-altipres 104

Alt-altipres 104
SPL v6
SPL
SPL Set ID c5a43107-3eb8-46bb-87bd-20deafe28c3f
Route
ORAL
Published
Effective Date 2025-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg)
Inactive Ingredients
Sucralose Citric Acid Monohydrate Fd&c Red No. 40 Glycerin Methylparaben Polyethylene Glycol, Unspecified Propylparaben Water Sodium Citrate Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-05-01

Description

Active Ingredients (in each 5 mL tsp.)              Purpose Dextromethorphan HBr ............... 10 mg ................ Cough Suppressant Guaifenesin .............................. 200 mg ................ Expectorant Phenylephrine HCl ..................... 5 mg ................... Nasal Decongestant


Medication Information

Warnings and Precautions

Warnings

Ask a doctor before use if you have

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

When using this product, do not exceed recommended dosage



Stop use and ask doctor if

  • you get nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition
Indications and Usage

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves nasal congestion due to the common cold and cough due to minor throat and bronchial irritation

Dosage and Administration

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

adults and children 12 years of age and over

take 2 teaspoonfuls (10 mL) every 4 hours

children 6 to under 12 years of age

take 1 teaspoonful (5 mL) every 4 hours

children 2 years to under 6 years of age

take 1/2 teaspoonful (2.5 mL) every 4 hours

children under 2 years of age

ask a doctor

Description

Active Ingredients (in each 5 mL tsp.)              Purpose Dextromethorphan HBr ............... 10 mg ................ Cough Suppressant Guaifenesin .............................. 200 mg ................ Expectorant Phenylephrine HCl ..................... 5 mg ................... Nasal Decongestant

Section 50565-1

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

Section 50570-1


Do not use

  • 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 you are taking a prescription drug that contains an MAOI; ask a doctor or pharmacist before taking this product -Do not use- in a child under 2 years of age

Section 51727-6

Inactive ingredients citric acid, flavor, FD&C Red #40, flavor, glycerin, methylparaben, polyethylene glycol, 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

Section 55106-9

Active Ingredients (in each 5 mL tsp.)              Purpose

Dextromethorphan HBr ............... 10 mg ................ Cough Suppressant

Guaifenesin .............................. 200 mg ................ Expectorant

Phenylephrine HCl ..................... 5 mg ................... Nasal Decongestant


Structured Label Content

Indications and Usage (34067-9)

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • temporarily relieves nasal congestion due to the common cold and cough due to minor throat and bronchial irritation

Dosage and Administration (34068-7)

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

adults and children 12 years of age and over

take 2 teaspoonfuls (10 mL) every 4 hours

children 6 to under 12 years of age

take 1 teaspoonful (5 mL) every 4 hours

children 2 years to under 6 years of age

take 1/2 teaspoonful (2.5 mL) every 4 hours

children under 2 years of age

ask a doctor

Warnings and Precautions (34071-1)

Warnings

Ask a doctor before use if you have

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

When using this product, do not exceed recommended dosage



Stop use and ask doctor if

  • you get nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition
Section 50565-1 (50565-1)

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

Section 50570-1 (50570-1)


Do not use

  • 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 you are taking a prescription drug that contains an MAOI; ask a doctor or pharmacist before taking this product -Do not use- in a child under 2 years of age

Section 51727-6 (51727-6)

Inactive ingredients citric acid, flavor, FD&C Red #40, flavor, glycerin, methylparaben, polyethylene glycol, 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

Section 55106-9 (55106-9)

Active Ingredients (in each 5 mL tsp.)              Purpose

Dextromethorphan HBr ............... 10 mg ................ Cough Suppressant

Guaifenesin .............................. 200 mg ................ Expectorant

Phenylephrine HCl ..................... 5 mg ................... Nasal Decongestant


Advanced Ingredient Data


Raw Label Data

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