NITE-TIME COLD/FLU MEDICINE- acetaminophen liquid 
AptaPharma Inc.

----------

Active Ingredients

Drug Facts

Active ingredients (in each 30 mL dose cup)

Acetaminophen 650 mg   Dextromethorphan HBr 30 mg   Doxylamine Succinate 12.5 mg 

Purpose

Purpose

Pain reliever/fever reducer   Cough suppressant   Antihistamine 

Keep Out Of Reach Of Children

Keep out of reach of children.

Uses

Uses temporarily relieves cold/flu symptoms:


Warnings

Liver warning: This product contains acetaminophen. Severe liver damage
may occur if you take ● more than 4 doses (30 mL each) in 24 hours, which is
the maximum daily amount for this product ● with other drugs containing
acetaminophen ● 3 or more alcoholic drinks everyday while using this product.

Sore throat warning: If sore throat is severe, persists for more than 2 days,

is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Ask A Doctor

Ask a doctor before use if you have

Ask A Doctor Or Pharmacist

Ask a doctor or pharmacist before use

When Using This Product

When using this product

Stop Use And Ask A Doctor

Stop use and ask a doctor if

Pregnant Or Breast-Feeding

If pregnant or breast-feeding, ask a health professional before use.

Overdose Warning

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.

Directions

Directions


adults and children 12 years and over                     30 mL (2TBSP) every 6 hours
children 4 to under 12 years                                   ask a doctor
children under 4 years                                            do not use

Other Information

Other information

Inactive Ingredients

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

Do Not Use

Do not use

Package Label - Night Time Cold & Flu Relief

NDC 76281-501-28

AP SAFE

*COMPARE TO
the active ingredients in
VICKS® NYQUIL®

Night Time

Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Doxylamine Succinate – Antihistamine

Multi-Symptom
Cold & Flu Relief

Original Flavor

12 FL OZ (354 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences

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

Manufactured by: AptaPharma Inc.,
1533 Union Ave., Pennsauken, NJ 08110

12 OZ

501-28 12oz Botl

6 OZ

501-25 6 OZ

res

NITE-TIME  COLD/FLU MEDICINE
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-501
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
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 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76281-501-28354 mL in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
2NDC:76281-501-25177 mL in 1 BOTTLE; Type 0: Not a Combination Product03/09/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/09/2018
Labeler - AptaPharma Inc. (790523323)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(76281-501)

Revised: 12/2023
Document Id: cb6b6620-c09c-4a6c-b243-a04cb59768ba
Set id: 344440bc-d810-4296-93ec-e6ae6673856b
Version: 8
Effective Time: 20231211
 
AptaPharma Inc.