NIGHT TIME COLD AND FLU RELIEF LIQUID FILLED SOFTGELS- acetaminophen,dextromethrophan hbr,doxylamine succinate capsule, liquid filled

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active ingredients 
(in each Softgel)
Acetaminophen 325 mg............. Pain reliever/Fever reducer
Dextromethorphan HBr 15 mg..... Cough suppressant
Doxylamine succinate 6.25 mg ..... Antihistamine

INDICATIONS & USAGE

Uses
Temporarily relieves common cold/flu symptoms:

PURPOSE

cough due to minor throat & bronchial irritation
sore throat
headache
minor aches & pain
fever
runny nose & sneezing

WARNINGS

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4 doses 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 to make a child sleep

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, and 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 aduits as well as for 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 soft gels with water every 6 hours
Children 4 to under 12 years:  Ask a doctor
Children under 4 years:  Do not use

WHEN USING

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

OTHER SAFETY INFORMATION

Other information
Store at room temperature 20-25°C (68-77°F)
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 at 1-877-798-5944

Product Label: AP SAFE Night time cold/flu Softgels

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AP SAFE​® Nighttime                                                                              *Compare to the active ingredients

Cold/Flu Relief                                                                                        In Vicks​​® Nyquil​™ Cold & Flu Nighttime

                                                                                                                Relief LiquiCaps™

Acetaminophen

Dextromethorphan HBr/Doxylamine Succinate

 24 Softgels

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​® Nyquil​™ Liquicaps​™

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 WARNING AND PRODUCT INFORMATION.

resRes

INGREDIENTS AND APPEARANCE

NIGHT TIME COLD AND FLU RELIEF LIQUID FILLED SOFTGELS 
acetaminophen,dextromethrophan hbr,doxylamine succinate capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-603
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: 76281-603-03	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(76281-603)