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FDA LABEL GENERIC: Triprolidine MFR: RB Health (US) LLC

1 Daytime (dextromethorphan Hbr 20 Mg / Guaifenesin 400 Mg / Phenylephrine Hcl 10 Mg In 20 Ml Oral Solution) / 1 Nighttime (acetaminophen 650 Mg / Dextromethorphan Hbr 20 Mg / Phenylephrine Hcl 10 Mg / Triprolidine Hcl 2.5 Mg In 20 Ml Oral Solution) Pack

Table of Contents

DAYTIME MULTI-SYMPTOM COLD, FLU & SORE THROAT - Ages 6+ YRS.

Drug Facts

Active ingredients (in each 10 mL) Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant

Uses

temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pains sore throat headache stuffy nose sinus congestion and pressure temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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:

skin reddening blisters rash

If a 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 the child has

liver disease heart disease diabetes high blood pressure thyroid disease 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 the 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

nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

Keep out of reach of children.

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 even if you do not notice any signs or symptoms.

Directions

this product does not contain directions or complete warnings for adult use do not give more than directed (see Overdose warning) measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; do not give more than 5 doses in any 24-hour period children under 6 years of age: do not use

Other information

each 10 mL contains: sodium 6 mg store at 20-25°C (68-77°F) do not refrigerate

Inactive ingredients

ammonium glycyrrhizate, anhydrous citric acid, cochineal carmine, edetate disodium, flavors, glycerin (soy), maltodextrin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions?

1-866-MUCINEX (1-866-682-4639)

MULTI-SYMPTOM COLD & FLU NIGHTTIME – Ages 6+ YRS.

Drug Facts

Active ingredients (in each 10 mL) Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5 mg Nasal decongestant
Triprolidine HCl 1.25 mg Antihistamine

Uses

temporarily relieves these common cold and flu symptoms: minor aches and pains headache sore throat nasal congestion runny nose sneezing cough stuffy nose temporarily reduces fever controls cough to help your child get to sleep

Warnings

Liver warning

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

more than 1625 mg 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:

skin reddening blisters rash

If a 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. to make a child sleepy 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

liver disease heart disease diabetes high blood pressure thyroid disease glaucoma 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 the child is

taking the blood thinning drug warfarin taking sedatives or tranquilizers

When using this product

do not use more than directed (see Overdose warning) excitability may occur, especially in children may cause marked drowsiness sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

Keep out of reach of children.

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 even if you do not notice any signs or symptoms.

Directions

this product does not contain directions or complete warnings for adult use do not give more than directed (see Overdose warning) measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; do not give more than 4 doses in any 24-hour period children under 6 years of age: do not use

Other information

each 10 mL contains: sodium 6 mg store at 20-25°C (68-77°F) do not refrigerate

Inactive ingredients

ammonium glycyrrhizate, anhydrous citric acid, cochineal carmine, edetate disodium, flavors, glycerin (soy), maltodextrin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions?

1-866-MUCINEX (1-866-682-4639)

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224
Made in Mexico

PRINCIPAL DISPLAY PANEL - Kit Carton

Pediatrician Recommended †
NDC 63824-945-34

TRIPLE PACK INCLUDES:

2X DAYTIME
1X NIGHTTIME

Mucinex®
Children's

FREEFROM

MULTI-SYMPTOM
COLD, FLU
& SORE THROAT

ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER
DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT
GUAIFENESIN – EXPECTORANT
PHENYLEPHRINE HCl – NASAL DECONGESTANT

MULTI-SYMPTOM
COLD & FLU
NIGHTTIME

ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER
DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT
PHENYLEPHRINE HCl – NASAL DECONGESTANT
TRIPROLIDINE HCl – ANTIHISTAMINE

FREEFROM
ARTIFICIAL FLAVORS, COLORS & DYES • ALCOHOL & SUGAR

ELDERBERRY
& CHERRY NATURAL FLAVOR

AGES 6+ YRS.

THREE - 4 FL OZ (118 mL) bottles
TOTAL - 12 FL OZ (354 mL)