FDA.reportPublic FDA data

McKesson Nighttime & Daytime Cold & Flu Drug Facts

Manufacturer
Strategic Sourcing Services LLC
Effective date
2026-08-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-08-21 02:01:24

Label at a glance#

Productfoster and thrive daytime cold and flu relief nighttime cold and flu relief
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure14 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 • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 2 softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Storage and handling

• store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

Active ingredients (in each softgel) – Nighttime Cold & Flu

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Active ingredients (in each softgel) – Daytime Cold & Flu

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose – Nighttime Cold & Flu

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Purpose – Daytime Cold & Flu

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses – Nighttime Cold & Flu

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

Uses – Daytime Cold & Flu

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever

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, lasts 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 – Nighttime Cold & Flu

OTC - ASK DOCTOR SECTION

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

Ask a doctor before use if you have – Daytime Cold & Flu

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are – Nighttime Cold & Flu

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Ask a doctor or pharmacist before use if you are – Daytime Cold & Flu

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

When using this product – Nighttime Cold & Flu

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

When using the product – Daytime Cold & Flu

OTC - WHEN USING SECTION

do not use more than directed

Stop use and ask a doctor if – Nighttime Cold & Flu

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.

Stop use and ask a doctor if – Daytime Cold & Flu

OTC - STOP USE SECTION

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion 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 – Nighttime Cold & Flu

DOSAGE & ADMINISTRATION SECTION

  • take only as directed – see overdose warning
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

2 softgels with water every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Directions – Daytime Cold & Flu

DOSAGE & ADMINISTRATION SECTION

  • take only as directed – see overdose warning
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

2 softgels with water every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients – Nighttime Cold & Flu

INACTIVE INGREDIENT SECTION

D&C yellow no. 10, edible ink*, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Inactive ingredients – Daytime Cold & Flu

INACTIVE INGREDIENT SECTION

edible ink*, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Questions or comments?

OTC - QUESTIONS SECTION

Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO VICKS® DAYQUIL® COLD & FLU ACTIVE INGREDIENTS

Foster & Thrive™

DAYTIME

Cold & Flu Relief

Acetaminophen

Dextromethorphan HBr

Phenylephrine HCl

PAIN RELIEVER, FEVER REDUCER, COUGH SUPPRESSANT, NASAL DECONGESTANT

Alcohol Free | Antihistamine Free | Gluten Free

Non-Drowsy

Multi-Symptom Relief of:

• Aches/Fever

• Sore Throat

• Nasal Congestion

• Cough

• Headache

32 SOFTGELS

ACTUAL SIZE

COMPARE TO VICKS® NYQUIL® COLD & FLU ACTIVE INGREDIENTS

Foster & Thrive™

NIGHTTIME

Cold & Flu Relief

Acetaminophen

Dextromethorphan HBr

Doxylamine succinate

PAIN RELIEVER, FEVER REDUCER, COUGH SUPPRESSANT, ANTIHISTAMINE

Alcohol Free | Gluten Free

Multi-Symptom Relief of:

• Aches/Fever

• Sore Throat

• Sneezing

• Runny Nose

• Cough

• Headache

16 SOFTGELS

ACTUAL SIZE

580-km-daytime-nighttime-cold-and-flu-relief
580-km-daytime-nighttime-cold-and-flu-relief

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1028-1EA - Each70677-1028ebea119b-4454-4a59-a8e0-78839b0f2b5012024-01-04

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70677-102870677-1028-1
0113-10000113-1000-00
0113-21010113-2101-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL SOLUTION8KW3E207O2IACT
SORBITAN6O92ICV9RUIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL SOLUTION8KW3E207O2IACT
SORBITAN6O92ICV9RUIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-11-14full-release2026-06-01 00:37:34

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
foster and thrive daytime cold and flu relief nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLStrategic Sourcing Services LLCc1ecc56b-8052-4b0a-900a-dc93a24771bd2026-08-07WarningsExact identifier
ndc (package): 0113-2101-00
ndc (package): 70677-1028-1
ndc (package): 0113-1000-00
ndc (product): 70677-1028
ndc11 (package): 00113210100
ndc11 (package): 70677102801
ndc11 (package): 00113100000
spl id: 57e7c322-7212-4e0d-a81b-98ad5c71870d
spl set id: c1ecc56b-8052-4b0a-900a-dc93a24771bd

Reported adverse events (FAERS/openFDA)#

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