Otc - Active Ingredient
Drug Facts
Active ingredients Purpose
(in each 10 mL)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Childrens Cold Cough And Sore Throat Mixed Berry Liquid
FDA Label NDC 76281-519
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aptapharma Inc. for the product Childrens Cold Cough And Sore Throat Mixed Berry (NDC 76281-519). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, overdosage, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Acetaminophen ……....…….... Pain reliever/fever reducer
Dextromethorphan HBr …....Cough suppressant
Guaifenesin ………….....…..…. Expectorant
Phenylephrine HCI …...……….Nasal decongestant
Indications & Usage
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
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
Keep out of reach of children. In case of overdose, get
medical help or contact a Poison Control Center right
away.
Overdosage
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.
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 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
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
Otc - Questions
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 & 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
* Please review the disclaimer below.
