G-Supress DX: Package Insert and Label Information

G-SUPRESS DX — guaifenesin, dextromethorphan hydrobromide and phenylephrine hydrochloride syrup
KRAMER NOVIS

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredients (in each 1mL)

Dextromethorphan HBr, 5mg

Guaifenesin, 50mg

Phenylephrine HCl, 2.5mg

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • temporarily relieves:

• nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis)

• cough due to minor throat and bronchial irritation as may occur with the common cold

Warnings

Do not use in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has
• heart disease • thyroid disease • high blood pressure
• diabetes
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with asthma

When using this product do not exceed recommended dosage.

Stop use and ask a doctor if
• your child gets nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by fever
• 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.

Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

  • do not use more than 6 doses in any 24 hour period.
  • repeat every 4 hours.
  • measure with the dosage device provided. Do not use with any other device.
  • children 2 to under 6 years of age, 1 mL.
  • children under 2 years of age, consult a doctor.

Other information

  • Tamper Evident Feature: Do not use if cap seal is torn, broken or missing. For your protection, this bottle has an imprinted seal around the neck.
  • Store at controlled room temperature 15-30°C (59-86°F).
  • Avoid excessive heat and humidity.

Inactive Ingredients

citric Acid, FD&C red 40, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sodium saccharin.

Compare to Suppress-DX®

By the makers of Suppress-DX®

COUGH SUPPRESSANT

EXPECTORANT

NASAL DECONGESTANT

Cherry Flavor

Sugar & Alcohol FREE

Manufactured in the USA for Kramer-Novis, San Juan, PR 00917 — Tel: (787) 767-2072

Packaging

image description
(click image for full-size original)

G-SUPRESS DX
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride syrup
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-655
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 50 mg in 1 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
GLYCERIN
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SODIUM CITRATE, UNSPECIFIED FORM
SACCHARIN SODIUM
Product Characteristics
Color red (CHERRY RED) Score
Shape Size
Flavor CHERRY (SOUR CHERRY) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52083-655-01 30 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/29/2011
Labeler — KRAMER NOVIS (090158395)
Registrant — KRAMER NOVIS (090158395)

Revised: 10/2022 KRAMER NOVIS

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