Alt-igualtuss 106

Alt-igualtuss 106
SPL v6
SPL
SPL Set ID 5499be5e-aa88-4376-9a77-4cfa3a4c168f
Route
ORAL
Published
Effective Date 2020-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (28 mg) Guaifenesin (388 mg) Phenylephrine (10 mg)
Inactive Ingredients
Sucralose Citric Acid Monohydrate Menthol Methylparaben Glycerin Propylparaben Water Sodium Citrate Fd&c Yellow No. 6

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-03-01

Description

Active Ingredients (in each 5 mL tsp.)              Purpose Dextromethorphan HBr ............... 28 mg ................ Cough Suppressant Guaifenesin .............................. 388 mg ................ Expectorant Phenylephrine HCl ..................... 10 mg ................... Nasal Decongestant


Medication Information

Warnings and Precautions

Warnings

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 your doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of prostate gland
  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smopking, asthma, chronic bronchitis, or emphysema

Ask a doctor before use if you are taking sedatives, tranquilizers or drugs for depression or MAOI drugs.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • cough lasts for more than 7 days, comes back or occurs with a fever, rash or headache that lasts. These could be signs of serious condition.
Indications and Usage

Uses

  • temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
  • temporarily releives nasal congestion due to the common cold.
Dosage and Administration

Directions  Do not exceed more than 4 doses in 24 hours.

Adults and children over 12 years of age                   take 1 teaspoonful (5 mL) every 6-8 hours

Children 6 to under 12 years of age                          take 1/2 teaspoonful (2.5 mL) every 6-8 hours

Children under 6 years of age                                   consult a doctor before use

Description

Active Ingredients (in each 5 mL tsp.)              Purpose Dextromethorphan HBr ............... 28 mg ................ Cough Suppressant Guaifenesin .............................. 388 mg ................ Expectorant Phenylephrine HCl ..................... 10 mg ................... Nasal Decongestant

Section 50565-1

Keep out of reach of children.In case of accidental overdose, seek advice of a doctor or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients:Citric acid, FD&C Yellow #6, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

Section 51945-4

Section 53413-1

Questions or comments?1-786-507-1566

Monday-Friday 9:00AM -5:00PM

Section 53414-9

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

Section 55105-1

Purpose 

Cough Suppressant

Expectorant

Nasal Decongestant

Section 55106-9

Active Ingredients (in each 5 mL tsp.)              Purpose

Dextromethorphan HBr ............... 28 mg ................ Cough Suppressant

Guaifenesin .............................. 388 mg ................ Expectorant

Phenylephrine HCl ..................... 10 mg ................... Nasal Decongestant


Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
  • temporarily releives nasal congestion due to the common cold.
Dosage and Administration (34068-7)

Directions  Do not exceed more than 4 doses in 24 hours.

Adults and children over 12 years of age                   take 1 teaspoonful (5 mL) every 6-8 hours

Children 6 to under 12 years of age                          take 1/2 teaspoonful (2.5 mL) every 6-8 hours

Children under 6 years of age                                   consult a doctor before use

Warnings and Precautions (34071-1)

Warnings

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 your doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of prostate gland
  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smopking, asthma, chronic bronchitis, or emphysema

Ask a doctor before use if you are taking sedatives, tranquilizers or drugs for depression or MAOI drugs.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • cough lasts for more than 7 days, comes back or occurs with a fever, rash or headache that lasts. These could be signs of serious condition.
Section 50565-1 (50565-1)

Keep out of reach of children.In case of accidental overdose, seek advice of a doctor or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients:Citric acid, FD&C Yellow #6, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?1-786-507-1566

Monday-Friday 9:00AM -5:00PM

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a doctor 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 ............... 28 mg ................ Cough Suppressant

Guaifenesin .............................. 388 mg ................ Expectorant

Phenylephrine HCl ..................... 10 mg ................... Nasal Decongestant


Advanced Ingredient Data


Raw Label Data

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