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  5. Label Information: Meijer Maximum Strength Nighttime Cough Dm

FDA Label for Meijer Maximum Strength Nighttime Cough Dm

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. OTC - ASK DOCTOR/PHARMACIST
    7. WHEN USING THIS PRODUCT
    8. OTC - STOP USE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL

Meijer Maximum Strength Nighttime Cough Dm Product Label

The following document was submitted to the FDA by the labeler of this product Meijer Distribution 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.

Other



Drug Facts


Otc - Purpose



Active ingredients (in each 20 ml)Purposes

Dextromethorphan HBr, USP 30 mg

Cough suppressant

Doxylamine Succinate, USP 12.5 mg

Antihistamine


Uses



  • ▪temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • ▪temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • ▪runny nose
    • ▪sneezing
    • ▪itchy, watery eyes
    • ▪itching of the nose or throat
    • ▪controls the impulse to cough to help you sleep

Do Not Use



  • ▪to sedate a child or to make a child sleepy
  • ▪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.

Ask A Doctor Before Use If You Have



  • ▪trouble urinating due to an enlarged prostate gland
  • ▪glaucoma
  • ▪a cough that occurs with too much phlegm (mucus)
  • ▪a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers


When Using This Product



  • ▪do not use more than directed
  • ▪marked drowsiness may occur
  • ▪avoid alcoholic drinks
  • ▪alcohol, sedatives, and tranquilizers may increase drowsiness
  • ▪be careful when driving a motor vehicle or operating machinery
  • ▪excitability may occur, especially in children

Otc - Stop Use



Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.


Directions



  • •measure only with dosing cup provided
  • •keep dosing cup with product
  • •mL = milliliter
  • •do not take more than 4 doses in any 24-hour period
  • •this adult product is not intended for use in children under 12 years of age
    • agedose

    adults and children 12 years and over

    20 ml every 6 hours

    children under 12 years

    do not use


Other Information



  • ▪each 20 ml contains: sodium 14 mg
  • ▪store at room temperature.

Inactive Ingredients



anhydrous citric acid, FD&C Red #40, flavor, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.


Questions Or Comments?



1-866-467-2748


Principal Display Panel



meijer®

NDC 41250-758-04

Compare to Robitussin® Maximum Strength Nighttime Cough DM active ingredient*

For Ages 12 & Over


adult nighttime cough DM

DEXTROMETHORPHAN HBr 30mg/20mL (Cough Suppressant)
DOXYLAMINE SUCCINATE 12.5mg/20mL (Antihistamine)

MAXIMUM STRENGTH

Nighttime

RELIEF OF: Cough, Itchy Throat, Runny Nose

4 FL OZ (118 mL)

*This product is not manufactured or distributed by Pfizer Inc, distributor of Robitussin.®

Maximum Strength claim based on maximum levels of active ingredient per dose.

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

MEIJER PHARAMACISTS RECOMMENDED

MONEY BACK GUARANTEE

meijer adult nighttime cough DM Maximum Strength - robitussin 01

meijer adult nighttime cough DM Maximum Strength - robitussin 01


* Please review the disclaimer below.