Active Ingredients (In Each 10 Ml)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Cough Cold And Sore Throat Liquid
FDA Label NDC 0363-4050
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Cough Cold And Sore Throat (NDC 0363-4050). 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 active ingredients (in each 10 ml), purposes, uses, warnings, do not use, ask a doctor before use if your child has, ask a doctor or pharmacist before use if your child is, when using this product,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Uses
- temporarily relieves these common cold and flu symptoms:
- cough due to minor throat and bronchial irritation
- the intensity of coughing
- the impulse to cough to help your child get to sleep
- nasal congestion
- stuffy nose
- sore throat
- minor aches and pains
- headache
- temporarily reduces fever
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a 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 monprescription). 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.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
Ask A Doctor Before Use If Your Child Has
- liver disease
- heart disease
- high blood pressure
- diabetes
- thyroid disease
- cough that occurs with too much phlegm (mucus)
- a breathing problem such as chronic bronchitis
- persistent or chronic cough such as occurs with asthma
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
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion or cough gets worse or lasts more than 5 days
- redness or swelling is present
- new symptoms occur
- fever gets worse or lasts more than 3 days
- cough comes back, or occurs with a rash or headache that lasts.
These could be signs of a serious condition.
Keep Out Of Reach Of Children
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 (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
Directions
- this product does not contain directions or complete warnings for adult use
- do not give more than directed (see Overdose warning)
- do not give more than 5 doses in any 24-hour period
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 days unless directed by a doctor
- keep dosing cup with product
- use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- dose as follows, or as directed by a doctor
- mL=milliliter
- children 6 to under 12 years of age: 10 mL in dosing cup provided
- children under 6 years of age: do not use
Other Information
- each 10 mL contains: sodium 6 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients
anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to Children's Mucinex® Cold, Cough & Sore Throat active ingredients††
Children's
Cold, Cough & Sore Throat
ACETAMINOPHEN 325 mg /
PAIN RELIEVER / FEVER REDUCER
DEXTROMETHORPHAN HBr 10 mg /
COUGH SUPPRESSANT
GUAIFENESIN 200 mg / EXPECTORANT
PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTANT
- Relief from cough, sore throat, stuffy nose & chest congestion
- Breaks up mucus
AGES 6 - 11 YEARS
FL OZ (mL)
BERRY FLAVOR
††This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Cold, Cough & Sore Throat.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com
Package Label
WALGREENS Children's Cold, Cough & Sore Throat Berry Flavor
* Please review the disclaimer below.
