MUCUS RELIEF: Package Insert and Label Information

MUCUS RELIEF- guaifenesin tablet
SPIRIT PHARMACEUTICALS LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient (in each caplet)

Guaifenesin 400 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make
coughs more productive

Warnings

Do not use

■ for children under 12 years of age

Ask a doctor before use if you have

■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
■ cough accompanied by too much phlegm (mucus)

Stop use and ask a doctor if

■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. 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. 1-800-222-1222

Directions

■ do not exceed 6 caplets in 24 hours.

■ take with a full glass of water

■ adults and children 12 years of age and over: take 1 caplet every 4 hours with a full glass of water while symptoms
persist.
■ children under 12 years of age: do not use

Other information

■ store between 20-25°C (68-77°F)

Inactive ingredients

colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, polyvinyl pyrrolidone, sodium starch
glycolate, stearic acid

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

Mucus Relief

Guaifenesin 400mg

• Expectorant
• Thins and Loosens Mucus
• Relieves Chest Congestion

IA MR
(click image for full-size original)
MUCUS RELIEF
guaifenesin tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-4158
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 400 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
MALTODEXTRIN
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
Product Characteristics
Color white Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code EB
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68210-4158-1 1 BOTTLE in 1 BOTTLE contains a BOTTLE
1 15 TABLET in 1 BOTTLE This package is contained within the BOTTLE (68210-4158-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/10/2020
Labeler — SPIRIT PHARMACEUTICALS LLC (179621011)

Revised: 06/2021 SPIRIT PHARMACEUTICALS LLC

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