Children's Cold, Cough & Sore Throat mixed Berry Flavor
OTC - ACTIVE INGREDIENT SECTION
Drug Facts
Active ingredients Purpose(in each 10 mL)Acetaminophen 325 mgDextromethorphan HBr 10 mgGuaifenesin 200 mg Phenylephrine HCl 5 mg
OTC - PURPOSE SECTION
Purpose
Acetaminophen ……....…….... Pain reliever/fever reducerDextromethorphan HBr …....Cough suppressantGuaifenesin ………….....…..…. ExpectorantPhenylephrine HCI …...……….Nasal decongestant
INDICATIONS & USAGE SECTION
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
WARNINGS SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, getmedical help or contact a Poison Control Center rightaway.
OVERDOSAGE SECTION
Overdose warningTaking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help orcontact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even ifyou do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
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
| Children 6 to under 12 years of age | 10 mL every 4 hours |
| Children under 6 years of age | Do not use |
OTHER SAFETY INFORMATION
Other information• each 10 mL contains: sodium 5 mg• store between IS-30°C (59-86°F)• do not refrigerate• dosage cup provided
INACTIVE INGREDIENT SECTION
Inactive ingredientsanhydrous 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
OTC - QUESTIONS SECTION
Questions? Call weekdays from 9:30AM to 4:30 PM EST 1-877-798-5944
Maximum Strength MAX COLD & SINUS
AP SAFE NDC 76281-519-24
Compare to Mucinex® FAST-MAX™ Cold & SinusActive ingredients*Children's
Cold, Cough
& Sore Throat
Pain reliever/Fever ReducerCough SuppresantExpectorantNasal 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.
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