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NDC 68210-1160-03 MUCUS RELIEF 400 mg/1 Details

MUCUS RELIEF 400 mg/1

MUCUS RELIEF is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by SPIRIT PHARMACEUTICALS LLC. The primary component is GUAIFENESIN.

MedlinePlus Drug Summary

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 68210-1160-03
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	68210-1160
Product ID	68210-1160_ee122adf-2860-aab8-e053-2995a90aeb95
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	MUCUS RELIEF
Proprietary Name Suffix	n/a
Non-Proprietary Name	GUAIFENESIN
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	400
Active Ingredient Units	mg/1
Substance Name	GUAIFENESIN
Labeler Name	SPIRIT PHARMACEUTICALS LLC
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 68210-1160-03 (68210116003)

Pricing Information	N/A
NDC Package Code	68210-1160-3
Billing NDC	68210116003
Package	1 BOTTLE in 1 CARTON (68210-1160-3) / 30 TABLET in 1 BOTTLE
Marketing Start Date	2018-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3fc2f580-0004-4718-95ce-f329266fe0f1 Details

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

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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 silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, polyvinyl pyrrolidone, sodium starch

glycolate, stearic acid

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL - 30 Caplet Bottle Carton

NDC 68210-1160-3

FAMILY wellness

Mucus Relief

Guaifenesin 400mg

• Expectorant

• Thins and Loosens Mucus

• Relieves Chest Congestion

30 CAPLETS

ACTUAL SIZE

INGREDIENTS AND APPEARANCE

MUCUS RELIEF

guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68210-1160
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	EB
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68210-1160-3	1 in 1 CARTON	12/01/2018
1		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	12/01/2018

Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)

Revised: 11/2022

Document Id: ee122adf-2860-aab8-e053-2995a90aeb95

Set id: 3fc2f580-0004-4718-95ce-f329266fe0f1

Version: 5

Effective Time: 20221122

Search by Drug Name or NDC

NDC 68210-1160-03 MUCUS RELIEF 400 mg/1 Details

MUCUS RELIEF 400 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 68210-1160-03 (68210116003)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 3fc2f580-0004-4718-95ce-f329266fe0f1 Details

Drug Facts

Active ingredient (in each caplet)

Purpose

Uses

SPL UNCLASSIFIED SECTION

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

Questions or comments?

PRINCIPAL DISPLAY PANEL - 30 Caplet Bottle Carton

INGREDIENTS AND APPEARANCE

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