FDA.reportPublic FDA data

Nighttime Cold and Flu Liquid Cherry

Manufacturer
Grimann, S.A. de C.V.
Effective date
2026-01-26
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:35:11

Label at a glance#

ProductNighttime Cold and Flu
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, ACETAMINOPHEN
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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 INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PURPOSE SECTION

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

OTC - ACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

p1p1p2p2p3p3p4p4p5p5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSN6
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD6
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY6
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY6
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81660-555-01Nighttime Cold and Flu Liquid Cherry30 mL in 1 BOTTLE, PLASTICLIQUID306
81660-777-01Nighttime Cold and Flu30 mL in 1 BOTTLE, PLASTICLIQUID306

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81660-77781660-777-01
81660-55581660-555-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALCOHOL3K9958V90MIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
CITRIC ACID ACETATEDSO12WL7AUIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
ACETAMINOPHEN362O9ITL9DACTIB
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT
ALCOHOL3K9958V90MIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
CITRIC ACID ACETATEDSO12WL7AUIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
ACETAMINOPHEN362O9ITL9DACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Cold and Flu Liquid CherryACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE SUCCINATEGrimann, S.A. de C.V.fe2dd0d7-36ff-154e-e053-6394a90a88d42026-01-26WarningsExact identifier
ndc (package): 81660-777-01
ndc (package): 81660-555-01
ndc (product): 81660-555
ndc (product): 81660-777
ndc11 (package): 81660077701
ndc11 (package): 81660055501
spl id: 494e38ca-85f0-abf1-e063-6294a90a36e5
spl set id: fe2dd0d7-36ff-154e-e053-6394a90a88d4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.