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Cough

Lake Erie Medical DBA Quality Care Products LLC

Rugby Cough SYRUP


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 5 mL teaspoonful)

Guaifenesin 100 mg

Cough 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

Cough 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

Image of Label

Cough

Cough

Guaifenesin LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:35356-851(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:35356-851-04 118 in 1 BOTTLE

Marketing Information

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


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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