Rugby Cough Syrup Guaifenesin, 4 Fl Oz (118 Ml)

Rugby Cough Syrup Guaifenesin, 4 Fl Oz (118 Ml)
SPL v2
SPL
SPL Set ID 7486c5ae-3e00-4c9f-bcb7-047a90af0f94
Route
ORAL
Published
Effective Date 2019-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Red No. 40 Potassium Citrate Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-04-20

Description

Drug Facts

Purpose

Expectorant

How Supplied

Product: 50436-1095 NDC: 50436-1095-1 1 mL in a CARTON / 118 in a BOTTLE


Medication Information

Purpose

Expectorant

How Supplied

Product: 50436-1095

NDC: 50436-1095-1 1 mL in a CARTON / 118 in a BOTTLE

Description

Drug Facts

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50566-9

Stop use and ask a doctor if cough last more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50569-3

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Section 53414-9

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

Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL=milliliter
  • this adult product is not intended for use in children under 12 years of age
age dose

adults and children 12 years and over

10 mL-20 mL every 4 hours

children under 12 years

do not use

Questions?

1-866-467-2748

Other Information
  • each 10 mL contains:sodium 4 mg
  • store at 20-25°C (68-77°F).
  • alcohol-free
Inactive Ingredients

citric acid, disodium edetate , FD&C red no. 40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Active Ingredient (in Each 10 Ml)

Guaifenesin, USP 200 mg

Rugby Cough Syrup Guaifenesin (guaifenesin) Liquid

Structured Label Content

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Section 42229-5 (42229-5)

Drug Facts

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 at 1-800-222-1222.

Section 50566-9 (50566-9)

Stop use and ask a doctor if cough last more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Section 53414-9 (53414-9)

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

Purpose

Expectorant

Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL=milliliter
  • this adult product is not intended for use in children under 12 years of age
age dose

adults and children 12 years and over

10 mL-20 mL every 4 hours

children under 12 years

do not use

Questions?

1-866-467-2748

How Supplied (HOW SUPPLIED)

Product: 50436-1095

NDC: 50436-1095-1 1 mL in a CARTON / 118 in a BOTTLE

Other Information (Other information)
  • each 10 mL contains:sodium 4 mg
  • store at 20-25°C (68-77°F).
  • alcohol-free
Inactive Ingredients (Inactive ingredients)

citric acid, disodium edetate , FD&C red no. 40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Active Ingredient (in Each 10 Ml) (Active ingredient (in each 10 mL))

Guaifenesin, USP 200 mg

Rugby Cough Syrup Guaifenesin (guaifenesin) Liquid (RUGBY COUGH SYRUP GUAIFENESIN (GUAIFENESIN) LIQUID)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)