Rugby®

Rugby®
SPL v1
SPL
SPL Set ID 5379a585-584d-45f5-9113-dffc277d5876
Route
ORAL
Published
Effective Date 2009-12-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg)
Inactive Ingredients
Caramel Citric Acid Monohydrate Corn Syrup Fd&c Red No. 40 Glycerin Menthol Propylene Glycol Water Sodium Benzoate Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-12-04

Description

Guaifenesin 100 mg


Medication Information

Description

Guaifenesin 100 mg

Uses

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

Section 50565-1

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

Section 50566-9

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.

Section 53413-1

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

Section 53414-9

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

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
Tamper Evident

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

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

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
Active Ingredient (in Each 5 Ml Teaspoonful)

Guaifenesin 100 mg

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)


Structured Label Content

Uses

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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.

Section 53413-1 (53413-1)

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

Section 53414-9 (53414-9)

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

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
Tamper Evident (TAMPER EVIDENT)

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

Other Information (Other information)
  • each teaspoonful contains: sodium 3 mg
  • store at room temperature 15°–30°C (59°–86°F)
Inactive Ingredients (Inactive ingredients)

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

Ask A Doctor Before Use If You Have (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
Active Ingredient (in Each 5 Ml Teaspoonful) (Active ingredient (in each 5 mL teaspoonful))

Guaifenesin 100 mg

Principal Display Panel 118 Ml Bottle Label (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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)