DAYTIME COLD AND FLU RELIEF LIQUID FILLED SOFTGELS- acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active ingredients
(in each Softgel)
Acetaminophen           325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl          5 mg

PURPOSE

Purposes
Acetaminophen               Pain reliever/Fever reducer
Dextromethorphan HBr    Cough suppressant
Phenylephrine HCl 5 mg   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 & pain
fever

WARNINGS

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you takemore than 8 softgels in
24 hours, 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.

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 cough 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 product, do 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 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 Warning)
do not exceed 4 doses per 24 hours
Adults & Children 12 years & over:         2 softgels with water every 4 hours
Children 4 to under 12 years:                    Ask a doctor
Children under 4 years:                             Do not use

When using other DayTime or Nighttime products, carefully read each label to ensure correct dosing.

STORAGE AND HANDLING

Other information
store at room temperature 20-25°C (68-77°F)
avoid excessive heat

INACTIVE INGREDIENT

Inactive ingredients
FD&C Red # 40, FD&C Yellow # 06, 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 at 1-877-798-5944

Product Label: AP SAFE Day Time Multi-Symptom Cold & Flu Relief Softgels

------------------------------------------------------

AP SAFE​®                                                                                             *Compare to the active ingredients

DayTime                                                                                                 In Vicks® Dayquil

Cold/Flu Relief                                                                                      Cold & Flu LiquiCaps

Acetaminophen

Dextromethorphan HBr / Phenylephrine HCI

24 Softgels

Headache, Fever,Sore Throat,
   Minor Aches & Pains
Nasal Congestion,
   Sinus Pressure
Cough

Manufactured by AptaPharma Inc.,

1533 Union Ave., Pennsauken, NJ 08110

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

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.

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INGREDIENTS AND APPEARANCE

DAYTIME COLD AND FLU RELIEF LIQUID FILLED SOFTGELS 
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-604
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	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	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: 76281-604-03	2 in 1 CARTON	01/01/2026
1		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 Drug	M012	01/01/2026

Labeler - AptaPharma Inc. (790523323)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(76281-604)