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.

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 55106-9

DRUG FACTS

Active ingredients

(in each 5 mL teaspoonful)

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 100 mg

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

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

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.

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 55106-9 (55106-9)

DRUG FACTS

Active ingredients

(in each 5 mL teaspoonful)

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 100 mg

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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