SCOT-TUSSIN DIABETES COUGH FORMULA WITH DM- dextromethorphan hydrobromide liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)
Available from:
SCOT-TUSSIN Pharmacal Co., Inc.
INN (International Name):
DEXTROMETHORPHAN HYDROBROMIDE
Composition:
DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Cough Suppressant - Temporarily quiets and calms a dry cough due to minor throat and bronchial irritation.
Authorization status:
OTC monograph final
Authorization number:
0372-0043-04

SCOT-TUSSIN DIABETES COUGH FORMULA WITH DM- dextromethorphan

hydrobromide liquid

SCOT-TUSSIN Pharmacal Co., Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Scot-Tussin Diabetes Cough Formula with DM

Active Ingredient

(in each 5 mL. tsp. teaspoon)

Dextromethorphan HBr. USP 10mg

Purpos e

Cough Suppressant

Us es

Temporarily quiets and calms a dry cough due to minor throat and bronchial irritation.

Warnings

Do not use

more than the recommended dosage.

If drowsiness occurs, do not drive or operate machinery.

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 two weeks after

stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a

doctor or pharmacists before taking this product.

Ask a doctor before use is you have

a chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.

difficulty in urination due to enlargement of the prostate gland.

Glaucoma.

Thyroid disease.

a chough that occurs with too much phlegm (mucus).

Stop use and ask a doctor if

Cough lasts more than seven days, returns or is accompanied by fever, rash or persistent headache.

These could be signs of a serious condition.

If pregnant or breast-feeding,

Do Not Use.

Keep out of reach of children.

In case of accidental overdose get medical help or contact a poison control center right away.

Directions

Follow Dosage Chart.

Do not take more than 6 doses in any 24 hour period.

This product is not intended for use in children under 12 years of age.

dose

Adults and children

over 12 years old

2 teaspoons

(2 tsp. 10 ml)

every 4 hours

Children Under

12 years old

DO NOT USE

Other Information

Store at 20º – 25º C (68º – 77º F).

Do not refrigerate.

Dosage cup provided.

Inactive Ingredients

Ammonium Glycyrrhizate, Citric Acid, Clear Cherry-Strawberry Flavor, Glycerin,

Hydroxyethylcellulose, Menthol, Methyl Paraben, Potassium Benzoate, Propyl Paraben, Propylene

Glycol, Purified Water.

Principal Display Panel

NDC 0372-0043-04

SCOT-TUSSIN

DIABETES

COUGH SUPPRESASANT Formula with DM

4 FL OZ (118 ml)

SCOT-TUSSIN DIABETES COUGH FORMULA WITH DM

dextromethorphan hydrobromide liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 372-0 0 43

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

10 mg

in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

AMMO NIUM GLYCYRRHIZATE (UNII: 3VRD35U26 C)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

GLYCERIN (UNII: PDC6 A3C0 OX)

HYDRO XYETHYL CELLULO SE ( 2 0 0 0 MPA.S AT 1%) (UNII: S38 J6 RZN16 )

MENTHO L (UNII: L7T10 EIP3A)

SCOT-TUSSIN Pharmacal Co., Inc.

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PO TASSIUM BENZO ATE (UNII: 76 3YQN2K7K)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

CHERRY, STRAWBERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 372-0 0 43-0 4

118 mL in 1 BOTTLE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt341

0 3/18 /19 9 8

Labeler -

SCOT -T USSIN Pharmacal Co., Inc. (001203918)

Revised: 1/2013

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