Label: CHILDRENS COLD COUGH AND SORE THROAT MIXED BERRY- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
- NDC Code(s): 76281-519-24
- Packager: AptaPharma Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 1, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
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 acetaminophenAllergy 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
- OVERDOSAGE
-
DOSAGE & 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 cupAge Dose 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
- INACTIVE INGREDIENT
- QUESTIONS
-
Maximum Strength MAX COLD & SINUS
AP SAFE NDC 76281-519-24
Compare to Mucinex® FAST-MAX™ Cold & Sinus
Active ingredients*
Children'sCold, Cough
& Sore Throat
Pain reliever/Fever Reducer
Cough Suppresant
Expectorant
Nasal decongestantFor 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
-
INGREDIENTS AND APPEARANCE
CHILDRENS COLD COUGH AND SORE THROAT MIXED BERRY
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76281-519 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 DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 10 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 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 blue Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76281-519-24 1 in 1 CARTON 01/30/2024 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 01/30/2024 Labeler - AptaPharma Inc. (790523323) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(76281-519)