NIGHTTIME COLD/FLU RELIEF SOFTGELS- acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled 
Pharmacy Value Alliance, 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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Nighttime Cold/Flu Relief Softgels

DRUG FACTS

Active ingredients (in each softgel)
Acetaminophen                325 mg
Dextromethorphan HBr      15 mg
Doxylamine Succinate     6.25 mg

Purpose
Acetaminophen …………….….Pain reliever/fever reducer
Dextromethorphan HBr .....Cough suppressant
Doxylamine succinate ……...Antihistamine

Uses temporarily relieves common cold/flu symptoms:
• cough due to minor throat and bronchial irritation
• sore throat • headache • minor aches & pains • fever
• runny nose and sneezing

Warnings Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
• more than 4 doses, in 24 hrs, which is the maximum daily amount
for this product with other drugs containing acetaminophen • 3
or more alcoholic drinks daily while using this product
Allergy Alert: Acetaminophen may cause severe skin
reactions. Symptoms may include:
• skin reddening • blisters • rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, lasts for more than 2
days, occurs with or is followed by fever, headache, rash,
nausea, or vomiting, consult a doctor promptly.

Do not use • with any other drug containing acetaminophen
(prescription or nonprescription). If you are not sure whether a drug
contains acetaminophen, ask a doctor or pharmacist
• if you are now taking a prescription monoamine oxidase inhibitor
(MAOI) (certain drugs for depression, psychiatric or emotional
conditions, or Parkinson's disease), or for 2 weeks after stopping the
MAOI drug. If you do not know if your prescription drug contains an
MAOI, ask a doctor or pharmacist before taking this product.
• to make a child sleepy

Ask a doctor before use if you have • liver disease • glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs
with smoking, asthma, chronic bronchitis or emphysema
• trouble urinating due to enlarged prostate gland.

Ask a doctor or pharmacist before use if you are
• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

When using this product do not use more than directed.
• excitability may occur, especially in children
• marked drowsiness may occur • avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives & tranquilizers may increase drowsiness

Stop use and ask a doctor if
• pain or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present • new symptoms occur
• cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.
In case of accidental overdose, get medical help or contact
a Poison Control Center right away. Quick medical attention is
critical for adults as well as children, even if you do not notice
any signs or symptoms.

Directions

• take only as directed (see Warnings)
• do not exceed 4 doses per 24 hrs

 adults & children 12 years & over 2 softgel with water every 6 hours
 children 4 to under 12 yrs ask a doctor
 children under 4 yrs do not use

when using other Daytime or Nighttime products,
  carefully read each label to ensure correct dosing

Other information
• Store at room temperature 20-25oC (68-77oF)
• avoid excessive heat

Inactive ingredients D&C yellow # 10, FD&C Blue # 1,
Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol,
Purified water, Sorbitol sorbitan solution, Titanium dioxide

Questions? Call weekdays from 9:30 am to 4:30 pm EST.
1-877-798-5944

Product Label

Premier
Value®

*COMPARE TO THE ACTIVE INGREDIENTS
IN VICKS® NYQUIL® COLD & FLU
NIGHTTIME RELIEF LIQUICAPS®

Nighttime

COLD/FLU RELIEF
Acetaminophen/ Dextromethorphan HBr/
Doxylamine Succinate

• Aches, Fever & Sore Throat
• Sneezing, Runny Nose
• Cough

16 Softgels

   INDEPENDENTLY TESTED
                PV
SATISFACTION GUARANTEED

Distributed by:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087

   INDEPENDENTLY TESTED
                 PV
SATISFACTION GUARANTEED

If for any reason you are not completely satisfied with
this product, please return it to the store
where purchased for a full refund.

Failure to follow these warnings
could result in serious consequences.

TAMPER EVIDENT: DO NOT USE IF
CARTON IS OPEN OR BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING.

KEEP OUTER BOX FOR COMPLETE
WARNINGS AND PRODUCT
INFORMATION.

BX-096

   5
098188
 1/20

16 Softgels Label

NiTime 881-16 Box

24 SofTgels Label

NiTime 881-24 Box

res

NIGHTTIME COLD/FLU RELIEF SOFTGELS 
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-881
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorgreenScoreno score
ShapeOVALSize20mm
FlavorImprint Code 603
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-881-162 in 1 CARTON02/28/2020
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:68016-881-242 in 1 CARTON02/28/2020
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/28/202012/31/2023
Labeler - Pharmacy Value Alliance, LLC (101668460)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(68016-881)

Revised: 12/2022
 
Pharmacy Value Alliance, LLC