Rugby- Chest Cong 1314

Rugby- Chest Cong 1314
SPL v7
SPL
SPL Set ID 51b088bc-b44f-44b9-a08e-133509a35a2c
Route
ORAL
Published
Effective Date 2025-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Red No. 40 Menthol Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-01

Description

Active ingredients Guaifenesin 100 mg


Medication Information

Warnings and Precautions

Warnings

Do not useif you ever had an allergic reaction to any of the indregients in this product

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

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

Indications and Usage

Uses

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

Dosage and Administration

Directions

  • Do not take more than 6 doses in a 24 hour period
  • Do not exceed recommended dose
 Adults and children 12 years and over  2 to 4 teaspoonfuls every 4 hours
 children under 12 years  ask a doctor

Description

Active ingredients Guaifenesin 100 mg

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 51727-6

Inactive ingredients. Artificial and natural cherry flavor, citric acid, FD&C Red #40, menthol, methylparaben, propylene glycol, propylparaben water, sodium citrate, sucralose

Section 51945-4

Section 53413-1

Questions or comments? 1-800-645-2158

Section 53414-9

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

Section 55105-1

Purpose

Expectorant

Section 55106-9

Active ingredients

Guaifenesin 100 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

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

Dosage and Administration (34068-7)

Directions

  • Do not take more than 6 doses in a 24 hour period
  • Do not exceed recommended dose
 Adults and children 12 years and over  2 to 4 teaspoonfuls every 4 hours
 children under 12 years  ask a doctor

Warnings and Precautions (34071-1)

Warnings

Do not useif you ever had an allergic reaction to any of the indregients in this product

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

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

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 51727-6 (51727-6)

Inactive ingredients. Artificial and natural cherry flavor, citric acid, FD&C Red #40, menthol, methylparaben, propylene glycol, propylparaben water, sodium citrate, sucralose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? 1-800-645-2158

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Expectorant

Section 55106-9 (55106-9)

Active ingredients

Guaifenesin 100 mg


Advanced Ingredient Data


Raw Label Data

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