Rite Aid Corporation Children’s Mucus Relief Multi-symptom Cold Drug Facts

Rite Aid Corporation Children’s Mucus Relief Multi-symptom Cold Drug Facts
SPL v4
SPL
SPL Set ID 4e88101a-a48d-4ea0-aa96-00c19a2ff860
Route
ORAL
Published
Effective Date 2024-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (100 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Red No. 40 Glycerin Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Solution Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-06-04

Description

Dextromethorphan HBr 5 mg Guaifenesin 100 mg Phenylephrine HCl 2.5 mg

Purpose

Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Cough suppressant Expectorant Nasal decongestant

Description

Dextromethorphan HBr 5 mg Guaifenesin 100 mg Phenylephrine HCl 2.5 mg

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help your child get to sleep
  • nasal congestion due to a cold
  • stuffy nose
Purposes

Cough suppressant

Expectorant

Nasal decongestant

Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL = milliliter

Age

Dose

children 6 years to under 12 years

10 mL every 4 hours

children 4 years to under 6 years

5 mL every 4 hours

children under 4 years

do not use

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 a doctor or pharmacist before giving this product.

Other Information
  • each 5 mL contains: sodium 3 mg
  • do not use if printed neckband is broken or missing
  • store at 20-25°C (68-77°F)
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments?

1-800-719-9260

When Using This Product

do not use more than directed

Stop Use and Ask A Doctor If
  • your child gets nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or occur with fever
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Active Ingredients (in Each 5 Ml)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Package/label Principal Display Panel

Compare to the active ingredients of Children’s Mucinex® Multi-Symptom Cold

FREE FROM

GLUTEN FREE

ALCOHOL FREE

FOR AGES 4 to 12 YEARS

CHILDREN’S MUCUS RELIEF MULTI-SYMPTOM COLD

DEXTROMETHORPHAN HBr

COUGH SUPPRESSANT

GUAIFENESIN

EXPECTORANT

PHENYLEPHRINE HCl

NASAL DECONGESTANT

NON-DROWSY

VERY BERRY FLAVOR

4 FL OZ (118 mL)

Ask A Doctor Before Use If the Child Has
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma

Structured Label Content

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help your child get to sleep
  • nasal congestion due to a cold
  • stuffy nose
Purposes

Cough suppressant

Expectorant

Nasal decongestant

Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL = milliliter

Age

Dose

children 6 years to under 12 years

10 mL every 4 hours

children 4 years to under 6 years

5 mL every 4 hours

children under 4 years

do not use

Do Not Use (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 a doctor or pharmacist before giving this product.

Other Information (Other information)
  • each 5 mL contains: sodium 3 mg
  • do not use if printed neckband is broken or missing
  • store at 20-25°C (68-77°F)
  • do not refrigerate
  • dosing cup provided
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, edetate disodium, FD&C red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-800-719-9260

When Using This Product (When using this product)

do not use more than directed

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • your child gets nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or occur with fever
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Active Ingredients (in Each 5 Ml) (Active ingredients (in each 5 mL))

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Compare to the active ingredients of Children’s Mucinex® Multi-Symptom Cold

FREE FROM

GLUTEN FREE

ALCOHOL FREE

FOR AGES 4 to 12 YEARS

CHILDREN’S MUCUS RELIEF MULTI-SYMPTOM COLD

DEXTROMETHORPHAN HBr

COUGH SUPPRESSANT

GUAIFENESIN

EXPECTORANT

PHENYLEPHRINE HCl

NASAL DECONGESTANT

NON-DROWSY

VERY BERRY FLAVOR

4 FL OZ (118 mL)

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma

Advanced Ingredient Data


Raw Label Data

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