Cough description, usages, side effects, indications, overdosage, supplying and lots more!

Cough

Rebel Distributors Corp

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Rugby Cough SYRUP

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 5 mL teaspoonful)

Guaifenesin 100 mg

Uses

helps loosen phlegm and thin bronchial secretions to rid the bronchial passageways of bothersome mucus

Warnings

Ask a doctor before use if you have

  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough 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 occurs with fever, 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.

Directions

  • take every four hours
  • do not take more than 6 doses in 24 hours
adults and children 12 years and over 2–4 teaspoonfuls
children 6 to under 12 years 1–2 teaspoonfuls
children under 6 years do not use

Other information

  • each teaspoonful contains: sodium 3 mg
  • store at room temperature 15°–30°C (59°–86°F)

Inactive ingredients

caramel powder, citric acid, corn syrup, FD&C red #40, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate

1-800-645-2158, 9 am – 5 pm ET, Monday – Friday

Purpose

TAMPER EVIDENT

DO NOT USE IF INNER FOIL SEAL OVER MOUTH OF BOTTLE IS BROKEN OR MISSING

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Rebel Distributors Corp
NDC 21695-705-04

  • FOR ADULTS AND CHILDREN
  • NON-NARCOTIC EXPECTORANT
  • ALCOHOL FREE

Cough
SYRUP
Guaifenesin, USP

4 fl oz (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Cough

Guaifenesin LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:21695-705(NDC:0536-0825)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Guaifenesin GUAIFENESIN 100 mg

Inactive Ingredients

Ingredient Name Strength
CARAMEL
CITRIC ACID MONOHYDRATE
CORN SYRUP
FD&C RED NO. 40
GLYCERIN
MENTHOL
propylene glycol
water
SODIUM BENZOATE
saccharin sodium

Product Characteristics

Color
PINK (Reddish-Pink)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:21695-705-04 118 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-12-04


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Be sure to consult your doctor before taking any medication!
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