DAYTIME COLD/FLU RELIEF SOFTGELS- acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled

Daytime Cold/Flu Relief Softgels by

Drug Labeling and Warnings

Daytime 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 10 mg
Phenylephrine HCl 5 mg

PURPOSE

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

INDICATIONS & USAGE

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

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 every day 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 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.

ASK DOCTOR

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

ASK DOCTOR/PHARMACIST

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

WHEN USING

When using this productdo not use more than directed.

STOP USE

Stop use and ask a doctor if
you get nervous, dizzy or sleepless
symptoms get worse or last more than 5 days (children) or 7
days (adults)
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 recommended (see Warnings)
do not exceed 4 doses per 24 hours

• adults & children 12 years & over: 2 softgel with water every 4 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 FD&C Red #40, FD&C Yellow #6,
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

Principal Display Package

Premier
Value®

*COMPARE TO THE ACTIVE INGREDIENTS
IN VICKS® DAYQUIL® LIQUICAPS®

Non-Drowsy

Daytime

COLD/FLU RELIEF
Acetaminophen / Dextromethorphan HBr / Phenylephrine HCl

Aches, Fever & Sore Throat
Nasal Congestion
Cough

Alcohol - Free

Antihistamine - Free

16 Softgels

**This product is not manufactured or distributed by
Procter & Gamble, owner of the registered trademark
Vicks® DayQuil® LiquiCaps®.

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.

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

KEEP OUTER CARTON FOR COMPLETE
WARNINGS AND PRODUCT
INFORMATION

BX-094

   9
987542
 1/20

res

INGREDIENTS AND APPEARANCE

DAYTIME COLD/FLU RELIEF SOFTGELS 
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-880
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	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
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	orange (to red)	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	604
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-880-16	2 in 1 PACKAGE	02/28/2020
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 68016-880-24	2 in 1 PACKAGE	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(68016-880) , repack(68016-880)