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NDC 71399-1005-08 Adult Tussin Mucus and Chest Congestion DM Sugar Free 200 mg/10mL Details

Adult Tussin Mucus and Chest Congestion DM Sugar Free 200 mg/10mL

Adult Tussin Mucus and Chest Congestion DM Sugar Free is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Akron Pharma Inc.. The primary component is GUAIFENESIN.

Product Information

NDC	71399-1005
Product ID	71399-1005_47feecd4-3cb6-445e-af79-5902ced2396f
Associated GPIs
GCN Sequence Number	022210
GCN Sequence Number Description	guaifenesin LIQUID 100 MG/5ML ORAL
HIC3	B3J
HIC3 Description	EXPECTORANTS
GCN	02512
HICL Sequence Number	000271
HICL Sequence Number Description	GUAIFENESIN
Brand/Generic	Generic
Proprietary Name	Adult Tussin Mucus and Chest Congestion DM Sugar Free
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dextromethorphan HBr, Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	200
Active Ingredient Units	mg/10mL
Substance Name	GUAIFENESIN
Labeler Name	Akron Pharma Inc.
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 71399-1005-08 (71399100508)

Pricing Information	N/A
NDC Package Code	71399-1005-8
Billing NDC	71399100508
Package	236 mL in 1 BOTTLE, PLASTIC (71399-1005-8)
Marketing Start Date	2022-11-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8a650a18-6738-4910-a663-731cc2cc93a1 Details

Active ingredients (in each 10 mL)

Guaifenesin 200 mg

Purposes

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

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

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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 take more than 6 doses in any 24-hour period
mL= milliliter
this adult product is not intended for use in children under 12 years of age
adults and children 12 years and over: 10- 20 mL every 4 hours
children under 12 years: do not use

Other information

store between 20-25ºC(68-77ºF). Do not refrigerate
protect from light
Pharmacist-Preserve and dispense in a tight, light-resistant container with a child resistant cap as defined in the USP.

Inactive ingredients

citric acid, flavor cherry, glycerin, menthol crystals, purified water, sodium benzoate, sodium saccharin, sorbitol solution.

Questions or comments?

1-877-225-6999

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ADULT TUSSIN MUCUS AND CHEST CONGESTION DM SUGAR FREE

dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71399-1005
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL SOLUTION (UNII: 8KW3E207O2)

Product Characteristics
Color	white (colorless)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71399-1005-4	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2022
2	NDC:71399-1005-8	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2022
3	NDC:71399-1005-6	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	11/11/2022

Labeler - Akron Pharma Inc. (067878881)

Registrant - SLV PHARMACEUTICALS LLC (081225162)

Name	Address	ID/FEI	Business Operations
Establishment
SLV PHARMACEUTICALS LLC		081225162	manufacture(71399-1005)

Revised: 11/2022

Document Id: 47feecd4-3cb6-445e-af79-5902ced2396f

Set id: 8a650a18-6738-4910-a663-731cc2cc93a1

Version: 1

Effective Time: 20221111