DESENFRIOL-D- chlorpheniramine maleate, phenylephrine hydrochloride, acetaminophen tablet 
Salimex, S.A.

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.

----------

Desenfriol-D

Active ingredient (in each caplet)

CHLORPHENIRAMINE MALEATE 2.0 mg

PHENYLEPHRINE HYDROCHLORIDE 5.0 mg

ACETAMINOPHEN 500 mg

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Uses

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

These could be signs of a serious condition.otc

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not take more than directed (see overdose warning)

adults and children 12 years and over

children under 12 years

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, D&C red #33, FD&C blue #1, FD&C red 40, flavors, glycerin, microrocrystalline cellulose, purified water, sodium benzoate, sorbitol, sucrose, xanthan gum

Desfriol-D

Desenfriol-D

DESENFRIOL-D 
chlorpheniramine maleate, phenylephrine hydrochloride, acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53666-417
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE0.002 g  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.005 g  in 1 g
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN0.5 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCROSE (UNII: C151H8M554)  
GLYCERIN (UNII: PDC6A3C0OX)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize18mm
FlavorImprint Code PME
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53666-417-0130 in 1 BOX10/18/2017
10.05 g in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/18/2017
Labeler - Salimex, S.A. (589201581)
Registrant - Salimex, S.A. (589201581)
Establishment
NameAddressID/FEIBusiness Operations
Bayer de México, S.A. de C.V.588165709manufacture(53666-417)

Revised: 12/2020
Document Id: b6d0934c-655e-6cf6-e053-2995a90ad1d9
Set id: 5bed1445-07d6-9b30-e053-2991aa0a3374
Version: 3
Effective Time: 20201219
 
Salimex, S.A.