health mart night time

Manufacturer
Strategic Sourcing Services LLC
Effective date
2023-07-14
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 21:28:44

Label at a glance#

Producthealth mart night time cold and flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure9 sections

Indications and uses

temporarily relieves common cold/flu symptoms: • cough due to minor throat and bronchial irritation • sore throat • headache • minor aches and pains • fever • runny nose and sneezing

Dosage and administration

• take only as directed – see Overdose warning • use dose cup • 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

Storage and handling

• each 30 mL contains: sodium 38 mg • store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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 a skin reaction occurs, stop use and seek medical help right away.

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.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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 2 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • 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

  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • 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 out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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

  • take only as directed – see Overdose warning
  • use dose cup
  • 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

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL contains: sodium 38 mg
  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Vicks® NyQuil® Cold & Flu active ingredients

NIGHTTIME RELIEF

NightTime

Cold & Flu

Acetaminophen, Doxylamine Succinate,

Dextromethorphan HBr

Pain Reliever/Fever Reducer,

Cough Suppressant, Antihistamine

Relieves:

Flu & Fever - Runny Nose & Sneezing

Cough & Sore Throat

ALCOHOL 10%

Gluten Free

12 Fl oz (355 mL)

335W6-nighttime.jpg
335W6-nighttime.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0083-1ML - Milliliter62011-008379bed680-e01d-4577-a968-34214819c42812012-07-24
62011-0083-2ML - Milliliter62011-0083c2ba4df6-4e2a-4ecb-8993-fd516dc0791a12013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D4
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH4
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI24
ACETAMINOPHENACTIVE MOIETY362O9ITL9D4
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS4
DOXYLAMINEACTIVE MOIETY95QB77JKPL4
ALCOHOLINACTIVE INGREDIENT3K9958V90M4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G4
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1S4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A84
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6S4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V34
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62011-008362011-0083-1, 62011-0083-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 318 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CONCENTRATE / ORAL0.03 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGEL / DENTAL0.3 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / SUBLINGUAL1 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYCAPSULE / ORAL24 mgExact identifier — unii candidate
34 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS414 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / VAGINAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPASTE / ORAL26 mgExact identifier — unii candidate
61 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii candidate
34 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAVENOUS16624 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8MOUTHWASH / BUCCAL0.01 mg/1mlExact identifier — unii candidate
34 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, DELAYED RELEASE / ORAL1.7 mgExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL48 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / OPHTHALMIC1 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, EXTENDED RELEASE / ORAL4.59 mgExact identifier — unii candidate
34 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSPRAY / NASAL5 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLFILM, SOLUBLE / BUCCAL2 mgExact identifier — unii candidate
61 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSPRAY / TOPICAL0.01 %w/wExact identifier — unii candidate
61 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, DELAYED RELEASE / ORAL1.9 mgExact identifier — unii candidate
31 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSPRAY, METERED / NASAL1.2 mg/1mlExact identifier — unii candidate
61 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SUSPENSION / ORAL570 mgExact identifier — unii candidate
61 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYELIXIR / ORAL15 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, EFFERVESCENT / ORAL840 mgExact identifier — unii candidate
61 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
34 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GPASTE / DENTALNAExact identifier — unii candidate
31 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GPOWDER, FOR SUSPENSION / ORAL76 mgExact identifier — unii candidate
31 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLFILM, SOLUBLE / ORAL7 mgExact identifier — unii candidate
61 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAMUSCULAR22 mgExact identifier — unii candidate
34 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, LIQUID FILLED / ORAL1.51 mgExact identifier — unii candidate
31 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii candidate
61 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
34 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE, EXTENDED RELEASE / ORAL12 mgExact identifier — unii candidate
61 equally ranked IID candidates
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1SCAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM / BUCCAL1.48 mgExact identifier — unii candidate
81 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / AURICULAR (OTIC)56.55 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLAEROSOL, FOAM / TOPICAL6 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPONGE / TOPICAL40 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GLOTION / TOPICALNAExact identifier — unii candidate
31 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GSUPPOSITORY / RECTAL0.11 mgExact identifier — unii candidate
31 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUPPOSITORY / VAGINAL252 mgExact identifier — unii candidate
81 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, EXTENDED RELEASE / ORAL3 mgExact identifier — unii candidate
31 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
81 equally ranked IID candidates

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
92ef822c-4da6-45ca-b1b7-6306c9699baf90e828d2-e691-47ff-adf4-b57472e5c5a72023-07-14WarningsExact identifier
spl id: 92ef822c-4da6-45ca-b1b7-6306c9699baf
spl set id: 90e828d2-e691-47ff-adf4-b57472e5c5a7

Reported adverse events (FAERS/openFDA)#

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