COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF- acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid

Cold and Flu Day Time Multi-Symptom Relief by

Drug Labeling and Warnings

Cold and Flu Day 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 15mL, 1tablespoon)
Acetaminophen           325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCI        5mg

PURPOSE

Purpose
Acetaminophen             Pain reliever/fever reducer
Dextromethorphan HBr   Cough suppressant
Phenylephrine HCI         Nasal decongestant

INDICATIONS & USAGE

Uses temporarily relieves these common cold/flu symptoms:
minor aches and pains headache sore throat fever
nasal congestion cough due to minor throat and bronchial irritation

WARNINGS

​Warnings
Liver warning: This product contains acetaminophen. Severe liver
damage may occur if adult/child takes:
more than 4doses in 24 hours, which is the maximum daily amount
for this product with other drugs containing acetaminophen
3or more alcoholic drinks everyday 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, persists for more than
2days, is accompanied or followed by fever, headache, rash, nausea,
or vomiting, consult a doctor promptly.

DO NOT USE

Do not use 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 two weeks after stopping the
MAOI drug. If you do not know if your prescription drug contains an
MAOI, ask a doctor or a pharmacist before taking this product.
with any other drug containing acetaminophen (prescription or
non-prescription). If you are not sure whether a drug contains
acetaminophen, ask a doctor or pharmacists.

ASK DOCTOR

Ask a doctor before use if you have
liver disease heart disease thyroid disease diabetes
high blood pressure trouble urinating due to enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma,
or emphysema cough accompanied by excessive phlegm (mucus)

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if the user is taking the
blood thinning drug warfarin

WHEN USING

When using this product do not use more than directed (see
overdose warning) avoid alcoholic drinks

STOP USE

Stop use and ask a doctor if you get nervous, dizzy or sleepless
new symptoms occur fever gets worse or lasts more than 3days
pain or cough gets worse or lasts more than 5days (children) or
7days (adults) redness or swelling is present
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 this and all drugs out of the reach of children.

OVERDOSAGE

Overdose Warning: Taking more than the recommended dose
(overdose) could cause serious health problems, including liver
damage. In case of accidental overdose, seek professional
assistance or contact a Poison Control Center immediately.
Quick medical attention is critical for adults as well as for
children even if you do not notice any signs or symptoms.

Keep this and all drugs out of the reach of children.

Keep this and all drugs out of the reach of children.

DOSAGE & ADMINISTRATION

Directions
take only as recommended (see overdose warning) use dosage
cup or tablespoon (TBSP) do not exceed 4doses per 24 hours

          age                          dose
adults and children            30 mL (2 TBSP)
12 years and over             every 4hours

children 6 to                    15 mL (1 TBSP)
under 12 years                 every 4 hours

children 4 years to            ask a doctor
under 6 years

children under 4 years        do not use

When using Day Time and Night Time products, carefully
read each label to ensure correct dosing.

OTHER SAFETY INFORMATION

Other information
sodium content per tablespoon: 10 mg
store at room temperature

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

Inactive ingredients
citric acid, FD&C Yellow #6, flavor, glycerin, propylene glycol
purified water, saccharin sodium, sodium benzoate, sucrose

QUESTIONS

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

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

Principal Display Panel

Premier® Value

COMPARE TO THE ACTIVE

INGREDIENTS IN

VICKS® DAYQUIL®*

COLD & FLU
Day Time Multi-Symptom Relief

Acetaminophen...... Pain Reliever/Fever Reducer
Dextromethorphan Hsr...... Cough Suppressant
Phenylephrine HCI........Nasal Decongestant

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®.
DISTRIBUTED BY: PHARMACY VALUE ALLIANCE, LLC
407 EAST LANCASTER AVENUE, WAYNE PA 19087

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

LR-028

REV-01

Product Label - 8 FL OZ

Product Label - 12 FL OZ

                                                                  Premier Value Cold & Flu Day Time Multi-Symptom Relief

INGREDIENTS AND APPEARANCE

COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF 
acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-236
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-236-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018
2	NDC: 68016-236-12	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(68016-236)