MENTHOL COUGH DROPS- menthol pastille 
LA TIA TRINI SA DE CV

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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Menthol Cough Drops

Menthol Cough Drops

Menthol 5 mg Purpose: Cough suppressant.

Purpose

Cough suppressant

Uses

Temporarily relieves:

Warnings

Sore throat warning if sore throat is severe, persists, for more than 2 days, is accompained or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. This symptoms may be serious.

Ask a doctor before use if you have:

• Persistent or chronic cough such as occurs with smoking, asthma, or emphysema. • Cough accompained by excessive phlegm (mocus).

When using this product

Do not exceed recommended dosage.

Keep out of reach of children

Stop use and ask a doctor if

Cough persists for more than 7 days, tends to recur, or is accompained by fever, rash, or persisstent headache. This could be signs of a serious condition.

Sore throat is severe, or irritation, pain or redness lasts or worsens.

If pregmant or breast-feeding Ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

Contains: Soy

Inactive Ingredients

Anhydrous dextrose, citric acid monohydrate, cordia boissieri whole, eucalyptus globulus leaf, FD&C Blue No.1, honey, mint, myrrh, propolis wax, sambucus nigra flower, soy lecithin, sucrose, verbascum densiflorum flower. Contains FD&C Yellow No. 5 (tartrazine) as a color additive.

Package Label - Menthol Drops

MentholDrops NDC: 72432-200-01

MentholDrops

MENTHOL COUGH DROPS 
menthol pastille
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72432-200
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.005 g  in 4 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
MYRRH (UNII: JC71GJ1F3L)  
MINT (UNII: FV98Z8GITP)  
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
HONEY (UNII: Y9H1V576FH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
VERBASCUM DENSIFLORUM FLOWER (UNII: N7FC535Q3R)  
CORDIA BOISSIERI WHOLE (UNII: 57NZE56C0Z)  
SUCROSE (UNII: C151H8M554)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize12mm
FlavorLIMEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72432-200-0136 g in 1 BLISTER PACK; Type 0: Not a Combination Product07/13/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/13/2021
Labeler - LA TIA TRINI SA DE CV (814376497)
Registrant - LA TIA TRINI SA DE CV (814376497)
Establishment
NameAddressID/FEIBusiness Operations
LA TIA TRINI SA DE CV814376497manufacture(72432-200)

Revised: 7/2021
Document Id: c84b3037-dc58-2b0e-e053-2995a90aedd1
Set id: c70507f3-b224-66e7-e053-2a95a90adeae
Version: 3
Effective Time: 20210729
 
LA TIA TRINI SA DE CV