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NDC 17856-1006-02 Adult Tussin Cough and Chest Congestion DM Sugar Free 20; 200 mg/10mL; mg/10mL Details

Adult Tussin Cough and Chest Congestion DM Sugar Free 20; 200 mg/10mL; mg/10mL

Adult Tussin Cough and Chest Congestion DM Sugar Free is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by ATLANTIC BIOLOGICALS CORP.. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.

Product Information

NDC	17856-1006
Product ID	17856-1006_773d490b-05ea-4986-8065-911bea8f0469
Associated GPIs
GCN Sequence Number	000652
GCN Sequence Number Description	guaifenesin/dextromethorphan LIQUID 100-10MG/5 ORAL
HIC3	B3T
HIC3 Description	NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION
GCN	53491
HICL Sequence Number	000223
HICL Sequence Number Description	GUAIFENESIN/DEXTROMETHORPHAN HBR
Brand/Generic	Generic
Proprietary Name	Adult Tussin Cough 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	20; 200
Active Ingredient Units	mg/10mL; mg/10mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Labeler Name	ATLANTIC BIOLOGICALS CORP.
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Ant
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 17856-1006-02 (17856100602)

Pricing Information	N/A
NDC Package Code	17856-1006-2
Billing NDC	17856100602
Package	72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-1006-2) / 10 mL in 1 CUP, UNIT-DOSE (17856-1006-4)
Marketing Start Date	2022-11-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 51b5dd53-e3ed-4e64-bc84-0aaa6ed95a8b Details

Active ingredients (in each 10 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

Purposes

Cough suppressant

Expectorant

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings

Do not use

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

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
measure only with dosing cup provided
keep dosing cup with product
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 mL every 4 hours
children under 12 years: do not use

Other information

Phenylketonurics: contains Phenylalanine 30 mg per 10 mL
store between 20-25ºC(68-77ºF). Do not refrigerate

Inactive ingredients

acesulfame potassium, citric acid, flavor cherry, glycerin, menthol crystals, purified water, sorbitol solution 70%, sodium citrate, sodium saccharin, sodium benzoate.

Questions or comments?

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP

MIAMI, FL 33179

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE

dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:17856-1006(NDC:71399-1006)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17856-1006-1	72 in 1 BOX, UNIT-DOSE	11/17/2022
1	NDC:17856-1006-3	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC:17856-1006-2	72 in 1 BOX, UNIT-DOSE	11/17/2022
2	NDC:17856-1006-4	10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

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

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Name	Address	ID/FEI	Business Operations
Establishment
UNIT DOSE SOLUTIONS		360804194	repack(17856-1006)

Revised: 11/2022

Document Id: 773d490b-05ea-4986-8065-911bea8f0469

Set id: 51b5dd53-e3ed-4e64-bc84-0aaa6ed95a8b

Version: 1

Effective Time: 20221111