NIGHTTIME COLD/FLU RELIEF SOFTGELS- acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled

Nighttime Cold/Flu Relief Softgels by

Drug Labeling and Warnings

Nighttime Cold/Flu Relief Softgels by is a Otc medication manufactured, distributed, or labeled by Pharmacy Value Alliance, LLC, AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

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

PURPOSE

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

INDICATIONS & USAGE

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

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

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 DOCTOR

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 DOCTOR/PHARMACIST

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

WHEN USING

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

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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

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

INACTIVE INGREDIENT

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

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

24 SofTgels Label

res

INGREDIENTS AND APPEARANCE

NIGHTTIME COLD/FLU RELIEF SOFTGELS 
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-881
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	green	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	603
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-881-16	2 in 1 CARTON	02/28/2020
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 68016-881-24	2 in 1 CARTON	02/28/2020
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/28/2020

Labeler - Pharmacy Value Alliance, LLC (101668460)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(68016-881) , repack(68016-881)