Active Ingredients (In Each Caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Cold And Flu Tablet, Film Coated
FDA Label NDC 49035-053
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores Inc for the product Cold And Flu (NDC 49035-053). 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 caplet), purpose, 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
Purpose
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Uses
- temporarily relieves these common cold and flu symptoms:
- sore throat
- cough
- nasal congestion
- headache
- minor aches and pains
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day 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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask A Doctor Before Use If You Have
- heart disease
- liver disease
- diabetes
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- thyroid disease
- cough that occurs with too much phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
- high blood pressure
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin.
When Using This Product
do not exceed recommended dosage.
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- 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.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
- adults and children 12 years and over
- take 2 caplets every 4 hours
- swallow whole - do not crush, chew, or dissolve
- do not take more than 10 caplets in 24 hours
- children under 12 years: ask a doctor
Other Information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
corn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Questions Or Comments?
1-888-287-1915
Principal Display Panel
equate™
NDC 49035-053-08
Compare to Tylenol® COLD + FLU SEVERE Active Ingredients*
Severe
Cold & Flu
Acetaminophen,
Dextromethorphan HBr,
Guaifenesin, Phenylephrine HCl
Pain Reliever/Fever Reducer,
Cough Suppressant, Expectorant,
Nasal Decongestant,
• Headache, fever, sore throat
• Nasal congestion
• Cough
• Mucus
• Chest congestion
24 CAPLETS Actual Size
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Satisfaction guaranteed - Or we'll replace it or give you your money back.
For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.
Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® COLD + FLU SEVERE.
50844 REV0316A50308
Equate 44-503a (Equate 44 503a Flu 1)
* Please review the disclaimer below.
