FDA Label for Cold And Flu Daytime Nighttime Severe
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 20 ML) (DAYTIME COLD & FLU)
- PURPOSE
- ACTIVE INGREDIENTS (IN EACH 20 ML) (NIGHTTIME SEVERE COLD & FLU)
- 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 (DAYTIME ONLY)
- DIRECTIONS (NIGHTTIME ONLY)
- OTHER INFORMATION
- INACTIVE INGREDIENTS (DAYTIME ONLY)
- INACTIVE INGREDIENTS (NIGHTTIME ONLY)
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
Cold And Flu Daytime Nighttime Severe Product Label
The following document was submitted to the FDA by the labeler of this product Walgreen Company. 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 Cold & Flu)
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
Cough suppressant
Nasal decongestant
Antihistamine
Active Ingredients (In Each 20 Ml) (Nighttime Severe Cold & Flu)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
Triprolidine HCl 2.5 mg
Uses
- temporarily relieves these common cold and flu symptoms:
- sore throat
- nasal congestion
- stuffy nose
- minor aches and pains
- sneezing (Nighttime only)
- headache
- cough
- runny nose (Nighttime only)
- itching of the nose or throat (Nighttime only)
- itchy, watery eyes due to hay fever (Nighttime only)
- sinus congestion and pressure
- sore throat
- temporarily reduces fever
- controls cough to help you get to sleep
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime only)
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 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
- liver disease
- diabetes
- thyroid disease
- heart disease
- glaucoma (Nighttime only)
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
- high blood pressure
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)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
- avoid alcoholic beverages (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
- 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 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.
Do not take DAYTIME and NIGHTTIME products at the same time.
Directions (Daytime Only)
- do not take more than directed
- do not take more than 6 doses in any 24-hour period
- mL = milliliter
- only use the dose cup provided
- adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
- children under 12 years: do not use
Directions (Nighttime Only)
- do not take more than directed
- do not take more than 4 doses in any 24-hour period
- mL = milliliter
- only use the dose cup provided
- 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)
- 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, FD&C yellow #6, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions?
Call 1-800-910-6874
Principal Display Panel
DAY & NIGHT PACK
NDC 0363-4278-45
Walgreens
Maximum Strength • Relieves headache, body pain, |
NIGHTTIME ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER Maximum Strength • Relieves headache, body pain, |
2 – 6 FL OZ (177 mL) BOTTLES / TOTAL 12 FL OZ (355 mL)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING
Do not take Daytime Cold & Flu and Nighttime
Severe Cold & Flu at the same time.
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
DISTRIBUTED BY: WALGREEN CO.
DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2023 Walgreen Co.
†Our pharmacists recommend the Walgreens brand.
We invite you to compare to national brands.
††This product is not manufactured or distributed by RB Health (US) LLC, owner
of the registered trademarks Maximum Strength Mucinex® FAST-MAX® Cold &
Flu and NIGHTSHIFT® Severe Cold & Flu.
* Please review the disclaimer below.