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

NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81660-777
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg in 30 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81660-777-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/11/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	04/11/2023

NIGHTTIME COLD AND FLU LIQUID CHERRY
acetaminophen, dextromethorphan, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81660-555
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg in 30 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81660-555-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/11/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	04/11/2023

Labeler - Grimann, S.A. de C.V. (812806982)

Name	Address	ID/FEI	Business Operations
Establishment
Grimann, S.A. de C.V.		812806982	manufacture(81660-777, 81660-555) , label(81660-777, 81660-555)