CHILDRENS COLD COUGH AND SORE THROAT MIXED BERRY- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
AptaPharma Inc.
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Drug Facts
Active ingredients Purpose
(in each 10 mL)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Purpose
Acetaminophen ……....…….... Pain reliever/fever reducer
Dextromethorphan HBr …....Cough suppressant
Guaifenesin ………….....…..…. Expectorant
Phenylephrine HCI …...……….Nasal decongestant
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
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.
Keep out of reach of children. In case of overdose, get
medical help or contact a Poison Control Center right
away.
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.
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 information
• each 10 mL contains: sodium 5 mg
• store between IS-30°C (59-86°F)
• do not refrigerate
• dosage cup provided
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
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
CHILDRENS COLD COUGH AND SORE THROAT MIXED BERRY
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid |
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Labeler - AptaPharma Inc. (790523323) |
Registrant - AptaPharma Inc. (790523323) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
AptaPharma Inc. | 790523323 | manufacture(76281-519) |