Dabur Honitus Herbal Cough Drops - Honey

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 HONEY- 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 - Honey

Drug Facts

Active ingredient (in each lozenge)

Menthol 5.7 mg

Purpose

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 honey flavor, Corn syrup, FD& yellow #5 (Tartrazine), Ginger ( Zingiber officinalis) [Rhizome], Honey, Indian Gooseberry ( Phyllanthus emblica) [Fruit], Licorice ( Glycyrrhiza glabra) [Root], Sucrose, Turmeric ( Curcuma longa) [Rhizome], 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 and Sore Throat

Honey

24 Lozenges

NDC: 75349-005-24

HONITUS - HONEY 2022

DABUR HONITUS HERBAL COUGH DROPS  HONEY
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 75349-005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5.7 mg
Inactive Ingredients
Ingredient NameStrength
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)  
Product Characteristics
Colorbrown (Yellowish brown) Scoreno score
ShapeROUNDSize18mm
FlavorHONEYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75349-005-242 in 1 CARTON02/25/202102/26/2021
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/25/202102/26/2021
Labeler - Dabur International Limited (851038067)

Revised: 11/2022
Document Id: ed0f79d5-1812-85b7-e053-2a95a90a10b6
Set id: bc908ec0-3336-fcab-e053-2995a90a5da4
Version: 3
Effective Time: 20221109