OTC Medication Information: MUCUS RELIEF

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 illness.

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 crush, chew, or break caplet
  • 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. Do not exceed 6 caplets in 24 hours.
  • children under 12 years of age: do not use

Other information

  • store between 20-25°C (68-77°F)

Inactive ingredients

Colloidal sillicone dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, polyvinyl pyrrolidone, sodium starch glycolate, stearic acid

Questions or comments?

1-888-333-9792

DISTRIBUTED BY
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

PRINCIPAL DISPLAY PANEL — 15 Caplet Bottle Carton

ASSURED

EXPECTORANT

MUCUS

RELIEF

  • Guaifenesin 400 mg

Thins &

Loosens

Mucus,

Relieves Chest Congestion

Actual Size

PRINCIPAL DISPLAY PANEL -- 15 Caplet Bottle Carton
(click image for full-size original)
MUCUS RELIEF
guaifenesin tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-0116
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:68210-0116-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 15 TABLET in 1 BOTTLE This package is contained within the CARTON (68210-0116-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/15/2018
Labeler — SPIRIT PHARMACEUTICALS LLC (179621011)
Establishment
Name Address ID/FEI Operations
ELYSIUM PHARMACEUTICALS LTD 915664486 manufacture (68210-0116)

Revised: 11/2020 SPIRIT PHARMACEUTICALS LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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