Adult Tussin Expectorant

Manufacturer
Chain Drug Marketing Association, Inc. | AptaPharma, Inc.
Effective date
2023-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:16:30

Label at a glance#

ProductAdult Tussin Expectorant
Active ingredientGUAIFENESIN
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active ingredients 
(in each 5 mL teaspoon)

Guaifenesin, USP 100 mg

OTC - PURPOSE SECTION

 Purpose

Expectorant

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

Ask a doctor before use if you have
■ cough that occurs with too much phlegm (mucus)
■ cough that lasts or is chronic such as occurs with
  smoking, asthma, chronic bronchitis, or
  emphysema

When using this product
■ do not use more than directed

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 condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose,

get medical help or contact a Poison Control center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

■ do not take more than 6 doses in any 24-hour period

Age                                        Dose
 Adults and children
12 years and over

 2-4 teaspoonfuls

every 4 hours

 Children under 12 years do not use

OTHER SAFETY INFORMATION

Other information
■ each 5 mL contains: sodium 3 mg
■ store between 20-25 ° C (68-77° F)
■ do not refrigerate
■ dosing cup provided
■ Keep carton for full directions for use

INACTIVE INGREDIENT SECTION

Inactive ingredients
Caramel, citric acid anhydrous, dextrose, FD&C red
#40, flavor, glycerin, high fructose corn syrup,
menthol, purified water, saccharin sodium, sodium
benzoate

OTC - QUESTIONS SECTION

Questions? Call weekdays from 9:30AM to 4:30
PM EST at 1-877-798-5944

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Adult                                                                     NDC 63868-039-04
Tussin
Expectorant
Guaifenesin
Oral Solution, USP

For Ages 12 & Over

Non-Drowsy

• Relieves Chest
  Congestion
• Loosens Mucus
• For ages 12 & Over

4 fl oz (118 mL)

*This product is not manufactured or distributed by
Pfizer, the distributor of Robitussin® Mucus plus
Chest Congestion.

Manufactured by:
AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110

Distributed by CDMA., Inc.
43157 W 9Nine Mile
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362

Tussin CrtonTussin Crton

Tusin BotlTusin Botl

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DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-039-04ML - Milliliter63868-039fa4010b9-6112-4afc-9840-63ef52856e1412022-09-12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-03963868-039-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3ac8c0a1-6080-4326-b5c6-312c552d5002c73dbb97-5f08-4b19-8961-4304f64c31732024-12-23WarningsExact identifier
spl set id: c73dbb97-5f08-4b19-8961-4304f64c3173

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.