Alt-altipresb 101

Alt-altipresb 101
SPL v7
SPL
SPL Set ID fd00c41d-0580-4177-afaa-60bb12ca5a09
Route
ORAL
Published
Effective Date 2025-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Phenylephrine (10 mg) Brompheniramine (4 mg)
Inactive Ingredients
Water Citric Acid Monohydrate Methylparaben Propylene Glycol Propylparaben Sodium Citrate Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-11-01

Description

Active Ingredients (in each 5 mL tsp)             Purpose Brompheniramine maleate 4 mg                                Antihistamine Dextromethorphan HBr 20 mg                                  Cough Suppressant  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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Do not use on a child under 2 years of age.



Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • glaucoma
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or a pharmacist before

  • giving this product to children who are taking sedatives or tranquilizers
  • if you are taking sedatives or tranquilizers

Indications and Usage

Uses

  • temporarily relieves symptoms due to hay fever or other upper respiratory allergies:
  • sneezing
  • itchy nose or throat
  • runny nose
  • itchy, water eyes
  • nasal congestion
  • temporarily controls cough due to minor throat and bronchial irritation associated with inhaled irritants
  • temporarily restores freer breathing through nose
Dosage and Administration

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

adults and children 12 years of age and over

take 1 teaspoonfuls (5 mL) every 4 hours

children 6 to under 12 years of age

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

children 2 years to under 6 years of age

ask a doctor

children under 2 years of age

do not use

Description

Active Ingredients (in each 5 mL tsp)             Purpose Brompheniramine maleate 4 mg                                Antihistamine Dextromethorphan HBr 20 mg                                  Cough Suppressant  Phenylephrine HCl 10 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 50570-1

Do not give this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, without first consulting the child's doctor.

When using this product

  • do not use more than directed
  • may cause drowsiness
  • avoid alcoholic drink
  • alcohol, sedatives and tranquilizers may increase drowsiness effect
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if





  • you get nervous, dizzy or sleeplessness
  • 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 51727-6

Inactive Ingredients citric acid, flavor, methylparaben, propylene glycol, propylparaben, pruified water, sodium citrate, and sucralose

Section 51945-4

Section 53413-1

Questions or comments: 1-305-403-3788

Alternative Pharmacal Corp. Miami Fl 33147

www.alternativepharmacal.com

Section 53414-9

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

Section 55105-1

Purpose

Antihistamine

Cough Suppressant

Nasal Decongestant

Section 55106-9

Active Ingredients (in each 5 mL tsp)             Purpose

Brompheniramine maleate 4 mg                                Antihistamine

Dextromethorphan HBr 20 mg                                  Cough Suppressant 

Phenylephrine HCl 10 mg                                      Nasal Decongestant


Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves symptoms due to hay fever or other upper respiratory allergies:
  • sneezing
  • itchy nose or throat
  • runny nose
  • itchy, water eyes
  • nasal congestion
  • temporarily controls cough due to minor throat and bronchial irritation associated with inhaled irritants
  • temporarily restores freer breathing through nose
Dosage and Administration (34068-7)

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

adults and children 12 years of age and over

take 1 teaspoonfuls (5 mL) every 4 hours

children 6 to under 12 years of age

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

children 2 years to under 6 years of age

ask a doctor

children under 2 years of age

do not 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Do not use on a child under 2 years of age.



Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • glaucoma
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or a pharmacist before

  • giving this product to children who are taking sedatives or tranquilizers
  • if you are taking sedatives or tranquilizers

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 50570-1 (50570-1)

Do not give this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, without first consulting the child's doctor.

When using this product

  • do not use more than directed
  • may cause drowsiness
  • avoid alcoholic drink
  • alcohol, sedatives and tranquilizers may increase drowsiness effect
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if





  • you get nervous, dizzy or sleeplessness
  • 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 51727-6 (51727-6)

Inactive Ingredients citric acid, flavor, methylparaben, propylene glycol, propylparaben, pruified water, sodium citrate, and sucralose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments: 1-305-403-3788

Alternative Pharmacal Corp. Miami Fl 33147

www.alternativepharmacal.com

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Antihistamine

Cough Suppressant

Nasal Decongestant

Section 55106-9 (55106-9)

Active Ingredients (in each 5 mL tsp)             Purpose

Brompheniramine maleate 4 mg                                Antihistamine

Dextromethorphan HBr 20 mg                                  Cough Suppressant 

Phenylephrine HCl 10 mg                                      Nasal Decongestant


Advanced Ingredient Data


Raw Label Data

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