OTC Medication Information: Mucus Relief

MUCUS RELIEF — guaifenesin tablet, extended release
Aphena Pharma Solutions — Tennessee, LLC

ACTIVE INGREDIENT(in each extended-release tablet)

Guaifenesin 600 mg

PURPOSE

Expectorant

USE(S)

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

WARNING

.

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 tablet
• 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 tablets every 12 hours.
• Do not exceed 4 tablets in 24 hours.
• children under 12 years of age: do not use

OTHER INFORMATION

• tamper evident: do not use if seal on the bottle printed “SEALED for YOU PROTECTION” is broken or missing.
• store between 20 to 25°C (68 to 77°F)

INACTIVE INGREDIENTS

carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

QUESTIONS?

1-800-616-2471

You may also report side effects to this phone number.

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma — TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count	600 mg
12	71610-499-12
60	71610-499-53

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506
20201217JH

PRINCIPAL DISPLAY PANEL — 600 mg

NDC 71610-499 — Guaifenesin ER 600 mg Tablets

MUCUS RELIEF guaifenesin tablet, extended release

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71610-499(NDC:0904-6986) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 600 mg

Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE HYPROMELLOSE, UNSPECIFIED CELLULOSE, MICROCRYSTALLINE POVIDONE, UNSPECIFIED

Product Characteristics Color WHITE Score no score Shape CAPSULE Size 22mm Flavor Imprint Code G233 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71610-499-12 12 TABLET, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:71610-499-53 60 TABLET, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209215 09/23/2019

Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)

Establishment
Name	Address	ID/FEI	Operations
Aphena Pharma Solutions — Tennessee, LLC		128385585	REPACK (71610-499)

Revised: 05/2021 Aphena Pharma Solutions — Tennessee, LLC