FDA.reportPublic FDA data

FAST DISSOLVING DAYTIME - NIGHTTIME COLD AND FLU

Manufacturer
RITE AID | TIME CAP LABS INC | MARKSANS PHARMA LTD
Effective date
2020-08-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:25:08

Label at a glance#

ProductFAST DISSOLVING DAYTIME - NIGHTTIME COLD AND FLU
Active ingredientGUAIFENESIN, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each softgel)

ACETAMINOPHEN 325MG

DEXTROMETHORHAN HBR10 MG,

GUAIFENESIN 200 MG

, PHENYLEPHRINE HCL 5 MG

INDICATIONS & USAGE SECTION

  • temporarily relieves common cold/flu symptoms: nasal congestion,headache, cough, minor aches and pains, sore throat
  • temoporarily reducces fever
  • prootes nasal and/or sinus drainage
  • helps ollsen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

WARNINGS SECTION

Warnings
Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take - more than 8sogtgels

This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 8 Softgels 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 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.

INACTIVE INGREDIENT SECTION

FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac,sorbitol sorbitan solution, titanium dioxide

DOSAGE & ADMINISTRATION SECTION

Do not take more than directed (See Overdose warning section) - do not exceed 12 Softgels per 24 hr period

  • adults & children 12 yrs & over 2 Softgels every 4 hrs
  • children 4 to under 12 yrs: Do not use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage.

In case of overdose, get medical help or contact a Poison Control Center right away. (1800-222-1222) 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

PAIN RELIEVER-FEVER REDUCER

COUGH SUPPRESENT

MINOR ACHES AND PAINS

CHEST CONGESTION

OTC - ACTIVE INGREDIENT SECTION


(in each softgel)
Acetaminophen 325mg

Dextromethorphan HBR 10 mg

Doxylamine Succinate 6.25 mg

PhenylephrineHCl 5mg

INDICATIONS & USAGE SECTION

Purpose

  • Pain reliever/Fever reducer
  • Cough suppressant
  • Antihistamine
  • Nasal decongestant

OTC - PURPOSE SECTION

MINOR ACHES AND PAINS, FEVER

NASAL CONGESTION AND SINUS PRESSURE

SNEEZING, RUNNY NOSE

COUGH

OTC - PURPOSE SECTION

PAIN RELIEVER-FEVER REDUCER

COUGH SUPPRESENT

MINOR ACHES AND PAINS

NASAL DECONGESTION

WARNINGS SECTION

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

  • more than 8 softgels 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 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.

DOSAGE & ADMINISTRATION SECTION

Directions
take only as directed - do not exceed 8 softgels per 24 hours -

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

INACTIVE INGREDIENT SECTION

FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

24 COUNT24 COUNT

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2634364{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } PackGPCK1
26343641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackPSN1
1297288acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSN1
1656815acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral CapsulePSN1
1297288acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD1
1656815acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD1
26343641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackSY1
1297288APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY1
1656815APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-7859-02025-01-30C16284748780-12cef2736-70ee-d83d-e063-dadaa90ab31f630T RITE AID COLD AND FLU FAST DISSOLVING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-7859-0FAST DISSOLVING DAYTIME - NIGHTTIME COLD AND FLU24 in 1 CARTONKIT241
11822-7859-0FAST DISSOLVING DAYTIME - NIGHTTIME COLD AND FLU1 in 1 BLISTER PACKKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-7859FAST DISSOLVING DAYTIME - NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIENESIN, PHENYLEPHRINE HCL,DOXYLAMINE SUCCINATE) KIT [RITE AID]1Legacy NDC, 2 package rows20200819_ad2ab189-9672-3322-e053-2995a90ac9e5.zip

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
11822-785911822-7859-0
11822-3685
11822-3684

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
GELATIN2G86QN327LIACT
SHELLAC46N107B71OIACT
POVIDONEFZ989GH94EIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
GUAIFENESIN495W7451VQACTIB
ACETAMINOPHEN362O9ITL9DACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GLYCERINPDC6A3C0OXIACT
GELATIN2G86QN327LIACT
SHELLAC46N107B71OIACT
SORBITOL506T60A25RIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
WATER059QF0KO0RIACT
POVIDONEFZ989GH94EIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
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
ad2a9db3-5b90-0f48-e053-2995a90ac010ad2ab189-9672-3322-e053-2995a90ac9e52020-08-18WarningsExact identifier
spl id: ad2a9db3-5b90-0f48-e053-2995a90ac010
spl set id: ad2ab189-9672-3322-e053-2995a90ac9e5

Reported adverse events (FAERS/openFDA)#

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