FDA Label for Severe Cold And Flu
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 20 ML)(DAYTIME)
- PURPOSE
- ACTIVE INGREDIENTS (IN EACH 20 ML)(NIGHTTIME)
- 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
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS (DAYTIME ONLY)
- INACTIVE INGREDIENTS (NIGHTTIME ONLY)
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Severe Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Wal-mart Stores Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each 20 Ml)(Daytime)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Pain reliever/fever reducer
Antihistamine/cough suppressant
Nasal decongestant
Active Ingredients (In Each 20 Ml)(Nighttime)
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
Uses
- temporarily relieves these common cold and flu symptoms:
- cough
- sore throat
- nasal congestion
- minor aches and pains
- headache
- runny nose and sneezing (Nighttime only)
- temporarily reduces fever
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime only)
- controls cough to help you get to sleep (Nighttime only)
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- with other drugs containing acetaminophen
- more than 4,000 mg of acetaminophen in 24 hours
- 3 or more alcoholic drinks every day while using this product
- 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
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
- with any other product containing diphenhydramine, even one used on skin (Nighttime only)
Ask A Doctor Before Use If You Have
- heart disease
- diabetes
- thyroid disease
- liver disease
- high blood pressure
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
- glaucoma (Nighttime only)
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Nighttime only)
When Using This Product
- do not exceed recommended dosage
- excitability may occur, especially in children (Nighttime only)
- marked drowsiness may occur (Nighttime only)
- avoid alcoholic beverages (Nighttime only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
- use caution when driving a motor vehicle or operating machinery (Nighttime only)
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
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- 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.
If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing. Do not take DAY & NIGHT at the same time.
Directions
- do not take more than directed
- do not take more than 6 doses in any 24-hour period
- mL = milliliter; FL OZ = fluid ounce
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
- children under 12 years: do not use
Other Information
- each 20 mL contains: sodium 10 mg (Daytime only), sodium 9 mg (Nighttime only)
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive Ingredients (Daytime Only)
anhydrous citric acid, disodium edetate, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum
Inactive Ingredients (Nighttime Only)
anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum
Questions Or Comments?
1-888-287-1915
Principal Display Panel
Equate™
Compare to Maximum Strength Mucinex® FAST-MAX® Day Time Severe Cold and Night Time Cold & Flu Active Ingredients†
NDC 49035-945-02
Maximum Strength Daytime Severe Cold ACETAMINOPHEN - Pain Reliever/Fever Reducer Multi-Symptom Relief • Relieves aches, fever & sore throat • Controls cough • Relieves nasal & chest congestion • Thins & loosens mucus Ages 12+ | Maximum Strength Nighttime Cold & Flu ACETAMINOPHEN - Pain Reliever/Fever Reducer Multi-Symptom Relief • Relieves aches, fever & sore throat • Controls cough • Relieves nasal congestion •Relieves runny nose & sneezing Ages 12+ |
TWO - 6 FL OZ (177 mL) BOTTLES TOTAL - 12 FL OZ (354 mL)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
PARENTS:
Learn about teen medicine abuse:
www.StopMedicineAbuse.org
Distributed by:Walmart Inc., Bentonville, AR 72716
†This product is not manufactured or distributed by Reckitt
Benckiser LLC, owner of the registered trademark Maximum
Strength Mucinex® FAST-MAX® Day Time Severe Cold &
Night time Cold & Flu.
50844 ORG021804201145
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.
* Please review the disclaimer below.