NIGHT TIME COUGH AND COLD RELIEF - diphenhydramine hydrochloride, phenylephrine hydrochloride liquid 
Chain Drug Consortium, LLC

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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Active ingredients

Drug Facts

Active ingredients
(in each 5 mL tsp)

Diphenhydramine HCL, USP 6.25 mg

Phenylephrine HCL, USP 2.5.mg

Purpose

Antihistamine / Cough suppressant

Nasal decongestant

Keep out of reach of children

Keep out of reach of children.

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

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


If pregnant or breast feeding,

ask a health professional before use.

Directions

AptaPharmaPV NightTime CCR1 Label


Other information

Inactive ingredients

acesulfame potassium, anhydrous citric acid, edetate disodium, FD and C Blue # 1, FD and C Red # 40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST 1-877-798-5944

Product Label

NDC68016-137-00

*COMPARE TO THE ACTIVE INGREDIENTS IN DELSYM® NIGHT TIME COUGH and COLD

Premier Value®

NIGHT TIME

COUGH and COLD RELIEF

Diphenhydramine HCL .......................Antihistamine/Cough Suppressant

Phenylephrine HCL ...........................Nasal Decongestant



Grape Flavored Liquid
4 FL OZ (120 mL)

INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

*This product is not manufactured or distributed by Reckitt Benckiser Inc. distributor of Children’s Mucinex® Multisymptom Cold
If for Any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

DISTRIBUTED BY
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431
BX-009

AptaPharmaPV NightTime CCR Label

NIGHT TIME COUGH AND COLD RELIEF 
diphenhydramine hydrochloride, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-137
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE6.25 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MALTITOL (UNII: D65DG142WK)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape Flavored Liquid) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-137-00120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2013
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(68016-137)

Revised: 4/2013
Document Id: 4bcbabca-b005-437d-86e5-f6c913ea9b3b
Set id: f61e8811-f70d-4f1f-a1b6-cf9d093dd12e
Version: 1
Effective Time: 20130401
 
Chain Drug Consortium, LLC