NYQUIL SEVERE COLD FLU- acetaminophen, dextromethorphan,phenyleprine liquid 
DAYQUIL COLD FLU- acetaminophen, dextromethorphan, doxylamine succinate liquid 
DAYQUIL SEVERE COLD FLU- acetaminophen, dextromethorphan, doxylamine succinate liquid 
NYQUIL COLD FLU- acetaminophen, dextromethorphan, doxylamine succinate liquid 
NYQUIL COLD FLU RELF CHERRY- acetaminophen, dextromethorphan, doxylamine succinate liquid 
Laboratorios Sanfer, S.A. de C.V.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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take only as directed

only use the dose cup provided
do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

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 skin reaction occurs, stop use and seek medical help right away

Sore throat warning: If sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Inactive ingredients alcohol, citric acid, D&C Yellow No. 10, FD&C Blue No.1, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose

Directions

take only as directed
only use the dose cup provided
do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

If pregnant or breast-feeding, ask a health professional before use. 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 for children even if you do not notice any signs or symptoms

Uses

temporarily relieves common cold/flu symptoms:

cough due to minor throat & bronchial irritation
sore throat
headache
minor aches & pains
fever

runny nose and sneezing

Active Ingredients (in each 30 mL) Purpose

Acetaminophen 650 mg……………………………………………………………………………………………………………….……….. Pain reliever/fever reducer

Dextromethorphan HBr 30 mg…………………………………………………………………………………………………….….………….……. Cough suppressant

Doxylamine succinate 12.5 mg………………………………………………………………………………………………………………………….……. Antihistamine

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NYQUIL SEVERE COLD FLU 
acetaminophen, dextromethorphan,phenyleprine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83393-636
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 30 mL
PHENYLEPHRINE (UNII: 1WS297W6MV) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE12.5 mg  in 30 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 1 mg  in 30 mL
SACCHARIN SODIUM (UNII: SB8ZUX40TY) 1 mg  in 30 mL
SODIUM BENZOATE (UNII: OJ245FE5EU) 1 mg  in 30 mL
SODIUM CITRATE (UNII: 1Q73Q2JULR) 1 mg  in 30 mL
SUCRALOSE (UNII: 96K6UQ3ZD4) 1 mg  in 30 mL
FD&C YELLOW NO. 6 (UNII: H77VEI93A8) 1 mg  in 30 mL
GLYCERIN (UNII: PDC6A3C0OX) 1 mg  in 30 mL
SORBITOL (UNII: 506T60A25R) 1 mg  in 30 mL
CITRIC ACID ACETATE (UNII: DSO12WL7AU) 1 mg  in 30 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1 mg  in 30 mL
MENTHOL (UNII: L7T10EIP3A) 1 mg  in 30 mL
XANTHAN GUM (UNII: TTV12P4NEE) 1 mg  in 30 mL
POVIDONE K30 (UNII: U725QWY32X) 1 mg  in 30 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83393-636-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/11/202312/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01204/11/202312/31/2023
DAYQUIL COLD FLU 
acetaminophen, dextromethorphan, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83393-736
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 1 mg  in 30 mL
SACCHARIN SODIUM (UNII: SB8ZUX40TY) 1 mg  in 30 mL
SODIUM BENZOATE (UNII: OJ245FE5EU) 1 mg  in 30 mL
SODIUM CITRATE (UNII: 1Q73Q2JULR) 1 mg  in 30 mL
SUCRALOSE (UNII: 96K6UQ3ZD4) 1 mg  in 30 mL
ALCOHOL (UNII: 3K9958V90M) 1 mg  in 30 mL
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) 1 mg  in 30 mL
GLYCERIN (UNII: PDC6A3C0OX) 1 mg  in 30 mL
SORBITOL (UNII: 506T60A25R) 1 mg  in 30 mL
CITRIC ACID ACETATE (UNII: DSO12WL7AU) 1 mg  in 30 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 1 mg  in 30 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1 mg  in 30 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83393-736-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/11/202312/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01204/11/202312/31/2023
DAYQUIL SEVERE COLD FLU 
acetaminophen, dextromethorphan, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83393-836
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 1 mg  in 30 mL
SACCHARIN SODIUM (UNII: SB8ZUX40TY) 1 mg  in 30 mL
SODIUM BENZOATE (UNII: OJ245FE5EU) 1 mg  in 30 mL
SODIUM CITRATE (UNII: 1Q73Q2JULR) 1 mg  in 30 mL
SUCRALOSE (UNII: 96K6UQ3ZD4) 1 mg  in 30 mL
ALCOHOL (UNII: 3K9958V90M) 1 mg  in 30 mL
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) 1 mg  in 30 mL
GLYCERIN (UNII: PDC6A3C0OX) 1 mg  in 30 mL
SORBITOL (UNII: 506T60A25R) 1 mg  in 30 mL
CITRIC ACID ACETATE (UNII: DSO12WL7AU) 1 mg  in 30 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 1 mg  in 30 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1 mg  in 30 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83393-836-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/11/202312/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01204/11/202312/31/2023
NYQUIL COLD FLU 
acetaminophen, dextromethorphan, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83393-536
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 1 mg  in 30 mL
SACCHARIN SODIUM (UNII: SB8ZUX40TY) 1 mg  in 30 mL
SODIUM BENZOATE (UNII: OJ245FE5EU) 1 mg  in 30 mL
SODIUM CITRATE (UNII: 1Q73Q2JULR) 1 mg  in 30 mL
SUCRALOSE (UNII: 96K6UQ3ZD4) 1 mg  in 30 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1 mg  in 30 mL
ALCOHOL (UNII: 3K9958V90M) 1 mg  in 30 mL
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) 1 mg  in 30 mL
GLYCERIN (UNII: PDC6A3C0OX) 1 mg  in 30 mL
SORBITOL (UNII: 506T60A25R) 1 mg  in 30 mL
CITRIC ACID ACETATE (UNII: DSO12WL7AU) 1 mg  in 30 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 1 mg  in 30 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83393-536-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/11/202312/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01204/11/202312/31/2023
NYQUIL COLD FLU RELF CHERRY 
acetaminophen, dextromethorphan, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83393-936
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 1 mg  in 30 mL
SACCHARIN SODIUM (UNII: SB8ZUX40TY) 1 mg  in 30 mL
SODIUM BENZOATE (UNII: OJ245FE5EU) 1 mg  in 30 mL
SODIUM CITRATE (UNII: 1Q73Q2JULR) 1 mg  in 30 mL
SUCRALOSE (UNII: 96K6UQ3ZD4) 1 mg  in 30 mL
ALCOHOL (UNII: 3K9958V90M) 1 mg  in 30 mL
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) 1 mg  in 30 mL
GLYCERIN (UNII: PDC6A3C0OX) 1 mg  in 30 mL
SORBITOL (UNII: 506T60A25R) 1 mg  in 30 mL
CITRIC ACID ACETATE (UNII: DSO12WL7AU) 1 mg  in 30 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 1 mg  in 30 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1 mg  in 30 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83393-936-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/11/202312/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01204/11/202312/31/2023
Labeler - Laboratorios Sanfer, S.A. de C.V. (810007732)
Establishment
NameAddressID/FEIBusiness Operations
Laboratorios Sanfer, S.A. de C.V.810007732manufacture(83393-536, 83393-636, 83393-736, 83393-836, 83393-936) , label(83393-536, 83393-636, 83393-736, 83393-836, 83393-936)

Revised: 5/2023
 
Laboratorios Sanfer, S.A. de C.V.