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  5. Label Information: Geri-tussin DM

FDA Label for Geri-tussin DM

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - PREGNANCY OR BREAST FEEDING
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DOSAGE & ADMINISTRATION
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENT
    10. QUESTIONS OR COMMENTS? 1-800-540-3765
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Geri-tussin DM Product Label

The following document was submitted to the FDA by the labeler of this product Geri-care Pharmaceuticals, Corp. 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.

Otc - Active Ingredient



in each 10 mL = 2 teaspoonfuls

Dextromethorphan HBr - 20 mg

Guaifenesin - 200 mg


Otc - Purpose



Purpose

Cough suppressant

Expectorant


Indications & Usage



Uses

  • temporarily relieves cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus)
  • helps thin bronchial secretions to make coughs more productive

Warnings



Warnings

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.

• if you have ever had an allergic reaction to any of the ingredients in this product.

Ask a doctor before use if you have

  • a cough with too much phlegm (mucus)
  • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

    • Stop use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, 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.In case of overdose, get medical help or contact a Poison Control Center right away.


Dosage & Administration



Directions

  • take every 4 hours as needed, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • do not exceed recommended dose
    •  Adults and children 12 years and over 10 mL (2 teaspoonfuls)
     Children under 12 years do not use


Other Information



  • each 10 mL contains: sodium 20 mg
  • store at room temperature 15°-30°C (59°-86°F)
  • protect from freezing
  • do not refrigerate
  • protect from light
  • TAMPER-EVIDENT:Do not use if foil seal over bottle opening is torn, broken or missing.
  • PHARMACIST:Preserve and dispense in a tight, light resistant container with a child resistant cap as defined in the USP.

Inactive Ingredient



Inactive ingredients:artificial and natural cherry flavor, citric acid, FD&C Red #40, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.


Questions Or Comments? 1-800-540-3765




Package Label.Principal Display Panel



Geri Care®

GERI - TUSSIN DM

SUGAR FREE ♦ ALCOHOL FREE

COUGH SUPPRESSANT

EXPECTORANT

For ages 12 years and over

Distributed by: GERI-CARE PHARMACEUTICALS CORP. 1295 Towbin Avenue Lakewood, NJ 08701

Code# L-011

REV.: 03/23

Principal Display - geritussindmPDL

Principal Display - geritussindmPDL


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