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  5. Label Information: Cold And Flu Non Drowsy Daytime And Nighttime

FDA Label for Cold And Flu Non Drowsy Daytime And Nighttime

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH SOFTGEL)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. OVERDOSAGE
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?
    17. PRINCIPAL DISPLAY PANEL

Cold And Flu Non Drowsy Daytime And Nighttime Product Label

The following document was submitted to the FDA by the labeler of this product Meijer, 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 Softgel)



COLD & FLU NON-DROWSY DAY RELIEF 

Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg

COLD & FLU NIGHT RELIEF

Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg

Doxylamine succinate 6.25 mg


Purposes



COLD & FLU NON DROWSY DAY RELIEF

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

COLD & FLU NIGHT RELIEF

Pain reliever/fever reducer

Cough suppressant

Antihistamine


Uses



temporarily relieves common cold/flu symptoms:

  • fever
  • headache
  • minor aches and pain
  • cough due to minor throat and bronchial iffitation
  • sore throat
  • nasal congestion (Daytime only)
  • runny nose and sneezing (Nighttime only)

Warnings



Liver warning This product contains acetaminophen. Severe liver damage may occur if you take: ● more than 4 doses in 24 hours, which is the
maximum daily amount for this product ● with other drugs containing acetaminophen ● 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions.
Symptoms may include: ● skin reddening ● blisters ● rash
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● to make a child sleepy (Nighttime only)


Ask A Doctor Before Use If You Have



● cough that occurs with too much phlegm (mucus) ● liver disease
● trouble urinating due to enlarged prostate gland
● diabetes (Daytime only) ● heart disease (Daytime only)
● thyroid disease (Daytime only) ● high blood pressure (Daytime only)
● persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only)
● a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (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 take more than directed
● marked drowsiness may occur (Nighttime only)
● avoid alcoholic drinks (Nighttime only)
● excitability may occur, especially in children (Nighttime only)
● be careful when driving a motor vehicle or operating machinery (Nighttime only)
● alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)


Stop Use And Ask A Doctor If



● you get nervous, dizzy or sleepless (Daytime only)
● pain, nasal congestion, or cough gets worse or lasts more than 7 days (Daytime only)
● pain or cough gets worse or lasts more than 7 days (Nighttime only)
● 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.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Overdosage



Overdose warning Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.


Directions



● when using other DAYTIME and NIGHTTIME products, carefully read each
label to ensure correct dosing

Directions (Daytime only)
● take only as directed - see Overdose warning
● do not exceed 4 doses per 24 hours

adults & children 12 years & overtake 2 softgels with water every 4 hours
children 4 to under 12 yearsask a doctor
children under 4 years of agedo not use

 ● when using other DAYTIME and NIGHTTIME products, carefully read each label to ensure correct dosing

Directions (Nighttime only)

● take only as directed - see Overdose warning
● do not exceed 4 doses per 24 hours

adults & children 12 years & overtake 2 softgels with water every 6 hours
children 4 to under 12 yearsask a doctor
children under 4 years of agedo not use


Other Information



  • store at room temperature.

Inactive Ingredients



DAY RELIEF

FD&C Red# 40, FD&C Yellow# 6, gelatin, glycerin, polyethylene glycol, myglyol, lecithin, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide 

NIGHT RELIEF

D&C Yellow# 10, FD&C Blue# 1, gelatin, glycerin, myglyol, lecithin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, polysorb, sorbitol sorbitan, titanium dioxide


Questions Or Comments?



1-888-333-9792


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