Label: CHILDRENS COLD, COUGH AND SORE THROAT- acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 68016-224-00 - Packager: Chain Drug Consortium, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 12, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Keep out of reach of children
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Sever liver damage may occur if your child if your child takes
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
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 drugs 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 two weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product.
- Ask a doctor before use if your child has
- Ask a doctor or pharmacist before use if
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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 that 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. -
Directions
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 dose cup
Age Dose
Children 6 to under 12 years of age 2 teaspoonfuls
Children under 6 years of age do not use - Other information
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Overdose warning
When using this product
- do not use more than directed (see 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.
- Inactive ingredients
- Questions?
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Product Label
NDC 68016-224-00
COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN’S MUCINEX® COLD, COUGH, and SORE THROAT LIQUID
Premier Value®
Children's Cold, Cough, and Sore Throat
Acetaminophen / Guaifenesin / Dextromethorphan HBr / Phenylephrine HCL
PAIN RELIEVER / FEVER REDUCER
EXPECTORANT
COUGH SUPPRESSANT
NASAL DECONGESTANT
Guaifenesin 100 mg
Dextromethorphan HBr 5 mg
Phenylephrine HCL 2.5 mg
* Cough
* Sore Throat
* Nasal Congestion
* Chest Congestion
For ages 6 to 12
Mixed Berry Flavor
4 FL OZ (118mL)
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV
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® Cold, Cough and Sore Throat Liquid
If for Any reason you are not satisfied with this product, lease return it to the store where purchased for a full refund.
DISTRIBUTED BY
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431
BX028 -
INGREDIENTS AND APPEARANCE
CHILDRENS COLD, COUGH AND SORE THROAT
acetaminophen, guaifenesin, dextromethorphan hbr, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-224 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 10 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 10 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 10 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYL GALLATE (UNII: 8D4SNN7V92) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor BERRY (MIXED BERRY) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-224-00 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/01/2013 Labeler - Chain Drug Consortium, LLC (101668460) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(68016-224)