Dabur Honitus Herbal Cough Drops - Mint

Dabur Honitus Herbal Cough Drops by

Drug Labeling and Warnings

Dabur Honitus Herbal Cough Drops by is a Otc medication manufactured, distributed, or labeled by Dabur International Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DABUR HONITUS HERBAL COUGH DROPS MINT- menthol lozenge 
Dabur International Limited

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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Dabur Honitus Herbal Cough Drops - Mint

Drug Facts

Active ingredient (in each lozenge)

Menthol 5.7 mg

Purposes

Cough suppressant / Oral anesthetic

Uses temporarily relieves

• cough as may occur with a cold or inhaled irritants
• occasional minor irritation, pain, sore mouth and sore throat

Warnings
Sore throat warning: If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly.

Ask a doctor before use if you have

• persistent or chronic cough such as occurs with smoking, asthma or emphysema
• cough accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

• cough lasts more than 7 days, tends to recur, or occurs with fever, rash or persistent headache. These could be signs of a serious condtion.
• sore mouth does not improve in 7 days
• irritation, pain or redness persist or worsen

Keep out of reach of children.

Directions

• adults and children 5 years and over: dissolve 1 lozenge slowly in the mouth
• repeat every 2 hours as needed
• children under 5 years: ask a doctor

Other information

store at room temperature in a dry place

Inactive ingredients

Artificial mint flavor, Corn syrup, FD&C Blue #1, FD& yellow #5 (Tartrazine), Ginger ( Zingiber officinalis) [Rhizome], Honey, Indian Gooseberry ( Phyllanthus emblica) [Fruit], Sucrose, Turmeric ( Curcuma longa) [Rhizome], Licorice (Glycyrrhiza glabra) [Root], Water

Mfd. for Dabur International Ltd, Jebel Ali Free zone,

Street No. N406, P.O. Box: 16944, Dubai, U.A.E.

Country of Origin: India

For adverse event reporting: Dabur International Ltd.

5 Independence Way - Suite 300 / Office # 46 & 50

Princeton, NJ 08540, Telephone: 609-514-5100

Dabur Honitus

HERBAL COUGH DROPS

Menthol - Cough Suppressant / Oral Anesthetic

with Honey & Ayurvedic Extracts

Relief from Cough & Sore Throat

Mint

24 Lozenges

NDC: 75349-007-24

DABUR HONITUS HERBAL COUGH DROPS  MINT
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75349-007
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	5.7 mg

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
GINGER (UNII: C5529G5JPQ)
CORN SYRUP (UNII: 9G5L16BK6N)
HONEY (UNII: Y9H1V576FH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
WATER (UNII: 059QF0KO0R)
PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)
LICORICE (UNII: 61ZBX54883)
TURMERIC (UNII: 856YO1Z64F)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	green	Score	no score
Shape	ROUND	Size	18mm
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75349-007-24	2 in 1 CARTON	02/25/2021	02/26/2021
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/25/2021	02/26/2021

Labeler - Dabur International Limited (851038067)

Revised: 11/2022

Document Id: ed0f8249-aba6-b67c-e053-2a95a90af7eb

34390-5

Set id: bc907a72-c237-91c3-e053-2995a90a83b0

Version: 3

Effective Time: 20221109