Active Ingredients (In Each 20 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Cold Flu And Sore Throat Relief Liquid
FDA Label NDC 21130-036
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safeway, Inc. for the product Cold Flu And Sore Throat Relief (NDC 21130-036). 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 20 ml), purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, 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:
- nasal congestion
- headache
- sinus congestion and pressure
- sore throat
- cough due to minor throat and bronchial irritation
- minor aches and pains
- temporarily reduces fever
- temporarily promotes nasal and/or sinus drainage
- 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 you take:
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
- 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
- for children under 12 years of age
- if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask A Doctor Before Use If You Have
- diabetes
- liver disease
- heart disease
- thyroid disease
- high blood pressure
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin.
When Using This Product,
do not use more than directed.
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 7 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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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 for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see overdose warning)
- do not take more than 6 doses in a 24-hour period
- measure only with dosing cup provided.Do not use any other dosing device.
- keep dosing cup with product
- dose as follows or as directed by a doctor
- mL = milliliter
- adults and children 12 years of age and older: 20 mL every 4 hours while symptoms last
- children under 12 years of age: do not use
Other Information
- each 20 mL contains: sodium 12 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients
anhydrous citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
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AGES 12 & OVER
Maximum Strength
Cold, Flu & Sore Throat Relief
Acetaminophen 650 mg
-Pain Reliever - Fever Reducer
Dextromethorphan HBr 20 mg
-Cough Suppressant
Guaifenesin 400 mg
-Expectorant
Phenylephrine HCl 10 mg
-Nasal Decongestant
Relief of: fever, aches, cough, stuffy nose, mucus & chest congestion
Compare to Maximum strength Mucinex®Fast-Max® Cold, Flu & Sore Throat active ingredients*
FL OZ (mL)
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Cold, Flu & Sore Throat.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
Package Label
SIGNATURE CARE Maximum Strength Cold, Flu & Sore Throat Relief
* Please review the disclaimer below.
