Childrens Mucus Relief description, usages, side effects, indications, overdosage, supplying and lots more!

Childrens Mucus Relief

Kroger Company

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Kroger Co. Children’s Mucus Relief Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each 5 mL)

Dextromethorphan HBr 5 mg

Guaifenesin 100 mg

Phenylephrine HCl 2.5 mg

Purpose

Cough suppressant

Expectorant

Nasal decongestant

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

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 a doctor or pharmacist before giving this product.

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

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)

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

Other information

  • •each 5 mL contains: sodium 3 mg
  • •store at 20-25°C (68-77°F)

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?

1-800-632-6900

Package/Label Principal Display Panel

COMPARE TO the active ingredients of CHILDREN’S MUCINEX® MULTI-SYMPTOM COLD

See back panel

Children’s Mucus Relief

MULTI-SYMPTOM COLD

Dextromethorphan HBr 5mg, Cough Suppressant

Guaifenesin 100 mg, Expectorant

Phenylephrine HCl 2.5 mg, Nasal Decongestant

Stuffy Nose

Cough

Chest Congestion

Breaks Up Mucus

Berry Flavor

4 FL OZ (118 mL)

Childrens Mucus Relief

dextromethorphan HBr, guaifenesin, phenylephrine HCl LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-839
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 5 mg
Guaifenesin GUAIFENESIN 100 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
EDETATE DISODIUM
FD&C RED NO. 40
GLYCERIN
propylene glycol
water
SODIUM BENZOATE
SODIUM CITRATE
sorbitol
Sucralose
XANTHAN GUM

Product Characteristics

Color
RED (clear)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:30142-839-26 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-05-17


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Be sure to consult your doctor before taking any medication!
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