children's mucus relief cough - cherry flavor

children's mucus relief cough - cherry flavor
SPL v4
SPL
SPL Set ID 9ae6fe74-80cd-482a-b3b9-3acafd6708ec
Route
oral
Published
Effective Date 2024-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (5 mg) guaifenesin (100 mg)
Inactive Ingredients
anhydrous citric acid dextrose d&c red no. 33 fd&c red no. 40 glycerin maltitol propylene glycol water saccharin sodium sodium benzoate sucralose xanthan gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
otc monograph drug active Since 2024-01-30

Description

DRUG FACTS Active ingredients (in each 5 mL teaspoonful) Dextromethorphan HBr, USP 5 mg Guaifenesin, USP 100 mg


Medication Information

Warnings and Precautions

Warnings

Do not use ina 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

• 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

• cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

These could be signs of a serious condition.

Active Ingredient

DRUG FACTS

Active ingredients

(in each 5 mL teaspoonful)

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 100 mg

Indications and Usage

Uses

• temporarily relieves:cough due to minor throat and bronchial irritation as may occur with a cold 

• helps loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tube

Dosage and Administration

Directions

•do not take more than 6 doses in any 24-hour period

                                  Age                                                                                            Dose

Children 6 years to

Under 12 years
1 to 2 teaspoonfuls (tsps)

every 4 hours
Children 4 years to

Under 6 years
1/2 to 1 teaspoonful (tsp)

every 4 hours
Children under 4 years do not use

Description

DRUG FACTS Active ingredients (in each 5 mL teaspoonful) Dextromethorphan HBr, USP 5 mg Guaifenesin, USP 100 mg

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 51727-6

Inactive ingredients: anhydrous citric acid, dextrose, D&C red

#33, FD&C red #40, flavors, glycerin, maltitol, propylene glycol,

purified water, saccharin sodium, sodium benzoate, sucralose,

xanthan gum

Section 53413-1

Questions? Call weekdays from 9:30AM to 4:30 PM EST 1-877-798-5944

Section 55105-1

Purpose

Dextromelhorphan HBr, USP ....... Cough Suppressant

Guaifenestn,USP ........................Expectorant

Section 60561-8

Other information • each teaspoon contains: sodium 3 mg

•store between 20-25°C (68-77°F) •do not refrigerate

•dosing cup provided • Keep carton for full direction for use

Children's Mucus Relief Cough Cherry

AP SAFE                        NDC 76281-512-24

Children's                                        

Cough

Mucus Relief

Cough Suppressant

Expectorant

Cherry Flavor

4 FL OZ (118 mL)

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

*This product is not manufactured or distributed by

Reckitt Benckiser Inc., distributor of Children's

Mucinex®Cough.

Manufactured by:

AptaPharma Inc.,

1533 Union Ave.

Pennsauken, NJ 08110

res


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Do not use ina 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

• 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

• cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

These could be signs of a serious condition.

Active Ingredient (55106-9)

DRUG FACTS

Active ingredients

(in each 5 mL teaspoonful)

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 100 mg

Indications and Usage (34067-9)

Uses

• temporarily relieves:cough due to minor throat and bronchial irritation as may occur with a cold 

• helps loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tube

Dosage and Administration (34068-7)

Directions

•do not take more than 6 doses in any 24-hour period

                                  Age                                                                                            Dose

Children 6 years to

Under 12 years
1 to 2 teaspoonfuls (tsps)

every 4 hours
Children 4 years to

Under 6 years
1/2 to 1 teaspoonful (tsp)

every 4 hours
Children under 4 years do not use

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 51727-6 (51727-6)

Inactive ingredients: anhydrous citric acid, dextrose, D&C red

#33, FD&C red #40, flavors, glycerin, maltitol, propylene glycol,

purified water, saccharin sodium, sodium benzoate, sucralose,

xanthan gum

Section 53413-1 (53413-1)

Questions? Call weekdays from 9:30AM to 4:30 PM EST 1-877-798-5944

Section 55105-1 (55105-1)

Purpose

Dextromelhorphan HBr, USP ....... Cough Suppressant

Guaifenestn,USP ........................Expectorant

Section 60561-8 (60561-8)

Other information • each teaspoon contains: sodium 3 mg

•store between 20-25°C (68-77°F) •do not refrigerate

•dosing cup provided • Keep carton for full direction for use

Children's Mucus Relief Cough Cherry (CHILDREN'S MUCUS RELIEF COUGH CHERRY)

AP SAFE                        NDC 76281-512-24

Children's                                        

Cough

Mucus Relief

Cough Suppressant

Expectorant

Cherry Flavor

4 FL OZ (118 mL)

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

*This product is not manufactured or distributed by

Reckitt Benckiser Inc., distributor of Children's

Mucinex®Cough.

Manufactured by:

AptaPharma Inc.,

1533 Union Ave.

Pennsauken, NJ 08110

res


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