COLD AND FLU NIGHT TIME MULTI-SYMPTOM RELIEF ORIGINAL- acetaminophen, dextromethorphan hbr, doxylamine succinate liquid

Cold and Flu Night Time Multi-Symptom Relief by

Drug Labeling and Warnings

Cold and Flu Night Time Multi-Symptom Relief 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 30 mL dose cup)
Acetaminophen                650 mg
Dextromethorphan HBr      30mg
Doxylamine Succinate     12.5 mg

PURPOSE

Purpose
Acetaminophen                 Pain reliever/fever reducer
Dextromethorphan HBr     Cough suppressant
Doxylamine Succinate       Antihistamine

INDICATIONS & USAGE

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

WARNINGS

Warnings
Liver warning: This product contains acetaminophen. Severe liver
damage may occur if you take
more than 4,000 mg of Acetaminophen in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product.

Allergy alert: Acetaminophen may cause severe skin reactions.
Symptoms may include: skin reddening blisters rash
If askin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than
two days, is accompanied or 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
a sodium restricted diet 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
if you are taking the blood thinning drug warfarin

WHEN USING

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

STOP USE

Stop use and ask a doctor if redness or swelling is present
symptoms do not get better within 7 days or are accompanied by a fever
fever gets worse or lasts more than 3 days new symptoms occur
cough lasts more than 7 days, comes back, or occurs with fever, 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.

OVERDOSAGE

Overdose warning: Taking more than the recommended dose can cause
serious health problems. In case of overdose, get medical help or contact a
Poison Control Center right away. Quick medical attention is critical for adults
as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions take only as recommended-see Overdose warning
Use dose cup or tablespoon (TBSP)
do not exceed 4 doses per 24 hours

adults and children 12              30 mL (2 TBSP)
years and over                         every 6 hours

children 4 to                             ask a doctor
under 12 years                     

children under 4years              do not use

If taking Night Time at night and Day Time during the day,
limit total to 4 doses per 24 hours.

OTHER SAFETY INFORMATION

Other information each 30 mL dose cup contains:
sodium 45 mg store at room temperature

INACTIVE INGREDIENT

Inactive ingredients citric acid, D&C yellow # 10, FD&C
Green No.3, FD&C Yellow No.6, flavor, glycerin,
polyethylene glycol, propylene glycol, purified water,
saccharin sodium, sodium benzoate, sodium citrate, sucrose

QUESTIONS

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

Principal Display Panel

Premier® Value

COMPARE TO THE ACTIVE

INGREDIENTS IN

VICKS® NYQUIL®*

Original Flavor

COLD & FLU
Night-time Multi-Symptom Relief

Acetaminophen...... Pain Reliever/Fever Reducer
Dextromethorphan Hbr...... Cough Suppressant
Doxylamine Succinate........Antihistamine

Non-drowsy

8 FL OZ (237 mL)

INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequences

Questions? Call weekdays 1-877-798-5944.
*This product is not manufactured or distributed by Proctor &
Gamble, owner of the registered trademark Vicks® NyQuil®.
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: PHARMACY VALUE ALLIANCE, LLC
407 EAST LANCASTER AVENUE, WAYNE PA 19087

LR-023

REV-01

Product label - 8 OZ Package

Product label - 12 OZ Package

                                                  Premier® Value Cold & Flu Night-time Multi-Symptom Relief Original

INGREDIENTS AND APPEARANCE

COLD AND FLU NIGHT TIME MULTI-SYMPTOM RELIEF  ORIGINAL
acetaminophen, dextromethorphan hbr, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-239
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-239-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018
2	NDC: 68016-239-12	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/01/2018

Labeler - Pharmacy Value Alliance, LLC (101668460)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(68016-239)