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NDC 81522-0006-60 caring mill mucus er 600 mg/1 Details

caring mill mucus er 600 mg/1

caring mill mucus er is a ORAL TABLET, MULTILAYER, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by FSA Store Inc.. 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: 81522-0006-60
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	81522-0006
Product ID	81522-006_591e2143-3e73-4504-9cab-fb66b7020c75
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	caring mill mucus er
Proprietary Name Suffix	n/a
Non-Proprietary Name	guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, MULTILAYER, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	600
Active Ingredient Units	mg/1
Substance Name	GUAIFENESIN
Labeler Name	FSA Store Inc.
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA078912
Listing Certified Through	2024-12-31

Package

Package Images

NDC 81522-0006-60 (81522000660)

Pricing Information	N/A
NDC Package Code	81522-006-60
Billing NDC	81522000660
Package	1 BOTTLE in 1 CARTON (81522-006-60) / 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date	2021-11-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a48ccd64-5c79-40f7-a524-0973b34ddb41 Details

Active ingredient (in each extended-release bi-layer caplet)

Guaifenesin 600 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
•: this product can be administered without regard for the timing of meals
•: adults and children 12 years of age and over: 1 or 2 caplets every 12 hours. Do not exceed 4 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

carbomer homopolymer type B, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate,

microcrystalline cellulose, sodium starch glycolate

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredient of Mucinex®

Mucus-ER

Guaifenesin Extended-Release Bi-Layer Tablets, 600 mg

Expectorant

12 Hour

• Relieves Chest Congestion

: • Thins and Loosens Mucus

• Immediate and Extended-Release

Actual Size

20 Extended-Release Bi-Layer Caplets*

*Capsule Shaped Tablets

INGREDIENTS AND APPEARANCE

CARING MILL MUCUS ER

guaifenesin tablet, multilayer, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81522-006
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	600 mg

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	L2X2
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:81522-006-60	1 in 1 CARTON	11/02/2021
1		20 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078912	11/02/2021

Labeler - FSA Store Inc. (049283340)

Revised: 11/2021

Document Id: 591e2143-3e73-4504-9cab-fb66b7020c75

Set id: a48ccd64-5c79-40f7-a524-0973b34ddb41

Version: 2

Effective Time: 20211109