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 11822-6179
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Cold And Flu (NDC 11822-6179). 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, stop use and ask a doctor if, 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:
- nasal congestion
- sore throat
- cough
- headache
- minor aches and pains
- sinus congestion and pressure
- 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 you take
- more than 4,000 mg of acetaminophen in 24 hours
- 3 or more alcoholic drinks every day while using this product
- with other drugs containing acetaminophen
- blisters
- rash
- skin reddening
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
- liver disease
- diabetes
- thyroid disease
- difficulty in urination due to enlargement of the prostate gland
- heart 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
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin.
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
- redness or swelling is present
- 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.
In case of accidental overdose, get medical help or contact a Poison Control Center 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
- do not take more than 12 caplets in any 24-hour period
- adults and children 12 years and over: take 2 caplets every 4 hours
- children under 12 years: do not use
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- use by expiration date on package
Inactive Ingredients
corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
Questions Or Comments?
1-800-426-9391
Principal Display Panel
NDC 11822-6179-9
MULTI-SYMPTOM RELIEF
*Compare to the active ingredients in
Maximum Strength Mucinex®
FAST-MAX®Cold & Flu
MAXIMUM STRENGTH
COLD & FLU
ACETAMINOPHEN
DEXTROMETHORPHAN HBr
GUAIFENESIN
PHENYLEPHRINE HCl
PAIN RELIEVER / FEVER REDUCER
COUGH SUPPRESSANT
EXPECTORANT
NASAL DECONGESTANT
Relieves Headaches, Body Pain,
Sore Throat, Fever, Cough,
Nasal & Chest Congestion,
Sinus Congestion & Pressure
ACTUAL SIZE
20
CAPLETS
TAMPER EVIDENT: DO NOT USE IF PACKAGE
IS OPENED OR IF BLISTER UNIT IS TORN,
BROKEN OR SHOWS ANY SIGNS OF TEMPERING
50844 ORG091861709
DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE,
CAMP HILL, PA 17011
www.riteaid.com
SATISFACTION GUARANTEE:
If you're not satisfied,
we'll happily refund your money.
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
Rite Aid 44-617cf (Rite Aid 44 617 Cf 1) 
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