Children's Cold, Cough & Sore Throat Mixed Berry Flavor

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg)

Inactive Ingredients

Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Propyl Gallate Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-01-30

Medication Information

Warnings and Precautions

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

• more than 5 doses in 24 hours, which is the maximum daily amount

• with other drugs containing acetaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include • skinreddening • blisters • rash. If skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • 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 your child has

• Iiver disease • heart disease • high blood pressure • thyroid disease • diabetes • a breathing problem such as chronic bronchitis • persistent or chronic cough such as occurs with asthma • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if • your child is taking the blood thinning drug warfarin.

When using this product • do not use more than directed (see Overdose warning)

Stop use and ask a doctor if

• redness or swelling is present

• nervousness, dizziness or sleeplessness occur

• new symptoms occur

• pain, nasal congestion or cough gets worse or lasts more than 5 days

• fever gets worse or lasts more than 3 days

• cough comes back, or occurs with rash or headache that lasts.

These could be signs of a serious condition.

Indications and Usage

Uses

• temporarily relieves these common cold and flu symptoms:

• nasal congestion • stuffy nose • minor aches and pains • sore throat • headache • fever

• cough due to minor throat and bronchial irritation

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

Dosage and Administration

Directions

• do not use more than directed (see Overdose warning)

• shake well before using

• do not use more than 5 doses in any 24-hour period

• if needed, repeat dose every 4 hours while symptoms last

• do not use more than 5 days unless directed by a doctor

• use dosage cup

Age Dose

Children 6 to under 12 years of age	10 mL every 4 hours
Children under 6 years of age	Do not use

Description

Drug Facts Active ingredients Purpose (in each 10 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Section 34088-5

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or

contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if

you do not notice any signs or symptoms.

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, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate,

purified water, sodium benzoate, sorbitol, 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

Acetaminophen ……....…….... Pain reliever/fever reducer

Dextromethorphan HBr …....Cough suppressant

Guaifenesin ………….....…..…. Expectorant

Phenylephrine HCI …...……….Nasal decongestant

Section 55106-9

Drug Facts

Active ingredients Purpose

(in each 10 mL)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Section 60561-8

Other information

• each 10 mL contains: sodium 5 mg

• store between IS-30°C (59-86°F)

• do not refrigerate

• dosage cup provided

Maximum Strength Max Cold & Sinus

AP SAFE NDC 76281-519-24

Compare to Mucinex^® FAST-MAX™ Cold & Sinus

Active ingredients*

Children's

Cold, Cough

& Sore Throat

Pain reliever/Fever Reducer

Cough Suppresant

Expectorant

Nasal decongestant

For Ages 6 to 12

Mixed Berry Flavor

4 FL OZ ( 118 mL)

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

Manufactured by:

AptaPharma Inc.,

1533 Union Ave.

Pennsauken, NJ 08110

* This product is not manufactured or distributed by Reckitt

Benckiser Inc., distributor ofchildren's Mucinex^® Cold,

Cough & Sore Throat liquid.

res

Structured Label Content

Indications and Usage (34067-9)

Uses

• temporarily relieves these common cold and flu symptoms:

• nasal congestion • stuffy nose • minor aches and pains • sore throat • headache • fever

• cough due to minor throat and bronchial irritation

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

Dosage and Administration (34068-7)

Directions

• do not use more than directed (see Overdose warning)

• shake well before using

• do not use more than 5 doses in any 24-hour period

• if needed, repeat dose every 4 hours while symptoms last

• do not use more than 5 days unless directed by a doctor

• use dosage cup

Age Dose

Children 6 to under 12 years of age	10 mL every 4 hours
Children under 6 years of age	Do not use

Warnings and Precautions (34071-1)