Night Time Cherry

Manufacturer
P & L Development, LLC
Effective date
2019-04-11
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-02 00:26:10

Label at a glance#

ProductNight Time Cherry Pseudo-Free
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure15 sections

Indications and uses

temporarily relieves these common cold/flu symptoms: • minor aches and pains • headache • muscular aches • sore throat • fever • runny nose and sneezing • itchy nose or throat • coughs • cough due to minor throat and bronchial irritation • itchy, watery eyes due to hay fever or other upper respiratory allergies

Dosage and administration

• use dosage cup or tablespoon (TBSP) • take only as recommended (see overdose warning) • do not exceed 4 doses per 24 hours age                                                                             dose adults and children 12 years and over................2 TBSPS (30 ml) every 6 hours children 4 years to under 12 years.......................do not use unless directed by a doctor children under 4 years.........

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg

Purposes

OTC - PURPOSE SECTION

Acetaminophen...........................................Pain reliever/fever reducer
Dextromethorphan HBr.....................................................Cough suppressant
Doxylamine succinate...............................................................Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these common cold/flu symptoms: • minor aches and pains
• headache • muscular aches • sore throat • fever • runny nose and sneezing
• itchy nose or throat • coughs • cough due to minor throat and bronchial irritation
• itchy, watery eyes due to hay fever or other upper respiratory allergies

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur
if you take: • more than 4 doses (8 tablespoonfuls or 120 mL) in 24 hours, which is the
maximum daily amount • with other drugs containing acetaminophen
• 3 or more alcoholic drinks everyday while using this product
Sore throat warning: Severe or persistent sore throat or sore throat that occurs with high
fever, headache, rash, nausea, and vomiting may be serious. Ask a doctor right away.
Do not use more than 2 days or give to children under 12 years of age unless directed
by a doctor.

Do Not Use

OTC - DO NOT USE SECTION

• to make a child sleepy • if you are on a sodium-restricted diet
• 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 two
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.
• with any other drug containing acetaminophen (prescription or non-prescription).
If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• liver disease • glaucoma • breathing problems
• chronic bronchitis • trouble urinating due to enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma or emphysema or if
cough is accompanied by excessive phlegm (mucus)

Ask a doctor or pharmacist before use if you are taking

OTC - ASK DOCTOR/PHARMACIST SECTION

• sedatives or tranquilizers • the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

• do not use more than directed (see overdose warning)
• 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 and ask a doctor if

OTC - STOP USE SECTION

• redness or swelling is present • new symptoms occur
• you get nervous, dizzy or sleepless • fever gets worse or lasts more than 3 days
• pain or cough gets worse or lasts more than 7 days
• cough comes back or occurs with rash or headache that lasts. These could be signs
of a serious condition.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep this and all drugs out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose Warning: Taking more than the recommended dose (overdose) could cause
serious health problems, including liver damage. In case of accidental overdose, seek
professional assistance or contact a Poison Control Center immediately. Quick medical
attention is critical for adults as well as for children even if you do not notice any signs
or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

• use dosage cup or tablespoon (TBSP)
• take only as recommended (see overdose warning)
• do not exceed 4 doses per 24 hours

age                                                                            dose
adults and children 12 years and over................2 TBSPS (30 ml) every 6 hours
children 4 years to under 12 years.......................do not use unless directed by a doctor
children under 4 years..........................................do not use

• When using Day Time and Night Time products,
carefully read each label to ensure correct dosing.

Other Information

SPL UNCLASSIFIED SECTION

• store at controlled room temperature
• sodium content per tablespoon: 18 mg

Inactive Ingredients

INACTIVE INGREDIENT SECTION

alcohol, blue 1, citric acid, flavor,
high fructose corn syrup, polyethylene glycol, propylene glycol,
purified water, red 40, saccharin sodium, sodium citrate

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aaron Brands

Night Time Cherry Flavor

Multi-Symptom Cold/Flu Relief

Compare to Active Ingredients in Vicks® NyQuil®

10% Alcohol

NET 4 FL OZ (118 mL)

image of label
image of label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D1
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYH1
Doxylamine SuccinateACTIVE INGREDIENTV9BI9B5YI21
AcetaminophenACTIVE MOIETY362O9ITL9D1
DextromethorphanACTIVE MOIETY7355X3ROTS1
DoxylamineACTIVE MOIETY95QB77JKPL1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49580-140349580-1403-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
7a940b19-b996-4a25-8af7-a5a40eeef738c3b0a638-d8bb-4044-ab69-ba5b28969d1b2019-04-11WarningsExact identifier
spl id: 7a940b19-b996-4a25-8af7-a5a40eeef738
spl set id: c3b0a638-d8bb-4044-ab69-ba5b28969d1b

Reported adverse events (FAERS/openFDA)#

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