RESPIRATORY RELIEF- guaifenesin tablet

Respiratory Relief by

Drug Labeling and Warnings

Respiratory Relief by is a Otc medication manufactured, distributed, or labeled by Schwabe North America, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Guaifenesin 400 mg

Inactive Ingredients

Carnauba Wax

Cellulose

Glycerin

Hypromellose

Magnesium Stearate

Maltodextrin

Povidone

Silica

Sodium Croscarmellose

Stearic Acid

Dosage & Administration

Adults & children 12 years of age and older:  take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not to exceed 6 tablets in 24 hours.

Children under 12 years of age: do not use.

Purpose

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

Indications & Usage

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

Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough accompanied by excessive phlegm (mucus).

Stop Use

Stop use and ask a doctor if cough lasts more than 7 days, tends to recur, or is accompanied by a fever, rash or persisient headache.

A persistent cough may be a sign of a serious condition.

Keep out of Reach of Children

Keep out of reach of children.

Pregnant or Breast Feeding

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

Overdosage:

In case of overdose, seek medical help or contact a Poison Control Center right away.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RESPIRATORY RELIEF 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-5295
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (Off-white to white)	Score	no score
Shape	OVAL (Convex face, debossed 400 tablet)	Size	18mm
Flavor		Imprint Code	400
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-5295-0	30 in 1 BOTTLE; Type 0: Not a Combination Product	07/29/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/29/2025

Labeler - Schwabe North America, Inc (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc		831153908	manufacture(53499-5295)