FDA.reportPublic FDA data

Sanaflu Xtra

Manufacturer
GRANDALL DISTRIBUTING, LLC
Effective date
2025-10-28
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:41:21

Label at a glance#

ProductSanaflu Xtra
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE
Label structure8 sections

Indications and uses

Temporarily relives minor aches and pains headache runny nose sneezing nasal congestion itchy, watery eyes due to hay fever or other upper respiratory allergies itching of the nose or throat cough due to minor throat and bronchial irritation as may occur with the common cold ro inhaled irritants Temperarily reduces fever

Dosage and administration

Adults and children 12 years of age and older: Take 2 capsules every 4 hours; not more than 12 capsules in 24 hours. Children under 12 years of age: Consult a doctor.

Storage and handling

Store at room temperature in a dry place.

Label contents#

Full prescribing information#

Active ingredients (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 250 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever - fever reducer

Antihistamine

Cough Suppressant

Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

  • Temporarily relives
  • minor aches and pains
  • headache
  • runny nose
  • sneezing
  • nasal congestion
  • itchy, watery eyes due to hay fever or other upper respiratory allergies
  • itching of the nose or throat
  • cough due to minor throat and bronchial irritation as may occur with the common cold ro inhaled irritants
  • Temperarily reduces fever

Warnings

WARNINGS SECTION

Liver warningThis 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.

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 monamine 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • heart disease
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland
  • persistant or chrnoic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm
  • thyroid disease
  • diabetes

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • may cause marked drowsiness
  • alcohol, sedativies, and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
  • may cause excitability, especially in children.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain, cough, or nasal congestion 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.
  • nervousness, dizziness, or sleeplessness occur.

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

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critial even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age and older: Take 2 capsules every 4 hours; not more than 12 capsules in 24 hours.
  • Children under 12 years of age: Consult a doctor.

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature in a dry place.

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red 33, FD&C Blue 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, polyvinylpyrrolidone, propylene glycol, sodium methylparaben, sodium propylparaben, water

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

boxboxdrug facts panel 1drug facts panel 1drug facts panel 2drug facts panel 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1193292acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN10
1193292acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD10
1193292APAP 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY10

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130348201018142GTIN-13: 0348201018142
EAN-13: 0348201018142
GTIN-12: 348201018142
UPC-A: 348201018142
GTIN storage (14 digits): 00348201018142		box.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48201-001-12Sanaflu Xtra12 in 1 BOXCAPSULE, GELATIN COATED1210

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D1
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9Z1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ1
ACETAMINOPHENACTIVE MOIETY362O9ITL9D1
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965U1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
GELATININACTIVE INGREDIENT2G86QN327L1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
METHYLPARABEN SODIUMINACTIVE INGREDIENTCR6K9C2NHK1
POLYETHYLENE GLYCOL 1000INACTIVE INGREDIENTU076Q6Q6211
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N91
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLPARABEN SODIUMINACTIVE INGREDIENT625NNB0G9N1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48201-00148201-001-12

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
METHYLPARABEN SODIUMCR6K9C2NHKIACT
PROPYLPARABEN SODIUM625NNB0G9NIACT
WATER059QF0KO0RIACT
ACETAMINOPHEN362O9ITL9DACTIB
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 600NL4J9F21N9IACT
POLYETHYLENE GLYCOL 1000U076Q6Q621IACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92024-01-23full-release2026-06-01 00:07:44

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 4 · 236 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii+route
40 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, SUGAR COATED / ORALNAExact identifier — unii+route
46 equally ranked IID candidates
POLYETHYLENE GLYCOL 600POLYETHYLENE GLYCOL 600NL4J9F21N9TABLET, DELAYED RELEASE / ORAL1 mgExact identifier — unii+route
12 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii+route
40 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDFILM, SOLUBLE / ORAL0.04 mgExact identifier — unii+route
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii+route
40 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKTABLET / ORAL0.19 mgExact identifier — unii+route
12 equally ranked IID candidates
PROPYLPARABEN SODIUMPROPYLPARABEN SODIUM625NNB0G9NPOWDER, FOR SUSPENSION / ORAL16 mgExact identifier — unii+route
12 equally ranked IID candidates
PROPYLPARABEN SODIUMPROPYLPARABEN SODIUM625NNB0G9NSUSPENSION / ORAL16 mgExact identifier — unii+route
12 equally ranked IID candidates
PROPYLPARABEN SODIUMPROPYLPARABEN SODIUM625NNB0G9NCAPSULE / ORAL1 mgExact identifier — unii+route
12 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDELIXIR / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, EXTENDED RELEASE / ORAL1229 mgExact identifier — unii+route
46 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKTABLET, ORALLY DISINTEGRATING / ORAL0.3 mgExact identifier — unii+route
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLPARABEN SODIUMPROPYLPARABEN SODIUM625NNB0G9NTABLET, ORALLY DISINTEGRATING / ORAL0.1 mgExact identifier — unii+route
12 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii+route
40 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKCAPSULE / ORAL2 mgExact identifier — unii+route
12 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
40 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii+route
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER / ORAL100 mgExact identifier — unii+route
46 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3ELIXIR / ORAL9306 mgExact identifier — unii+route
40 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / ORAL46 mgExact identifier — unii+route
46 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, ORALLY DISINTEGRATING / ORAL120 mgExact identifier — unii+route
46 equally ranked IID candidates
POLYETHYLENE GLYCOL 600POLYETHYLENE GLYCOL 600NL4J9F21N9TABLET, DELAYED RELEASE / ORAL1 mgExact identifier — unii+route
12 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii+route
44 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LCONCENTRATE / ORAL0.02 mg/1mlExact identifier — unii+route
24 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SOLUTION / ORAL0.04 mg/5mlExact identifier — unii+route
44 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKPOWDER, FOR SUSPENSION / ORAL80 mgExact identifier — unii+route
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLPARABEN SODIUMPROPYLPARABEN SODIUM625NNB0G9NSUSPENSION / ORAL16 mgExact identifier — unii+route
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii+route
40 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, CHEWABLE / ORAL24 mgExact identifier — unii+route
46 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii+route
40 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSYRUP / ORAL1 mgExact identifier — unii+route
24 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LCAPSULE / ORAL1 mgExact identifier — unii+route
24 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3ELIXIR / ORAL9306 mgExact identifier — unii+route
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii+route
40 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKSOLUTION / ORAL134 mgExact identifier — unii+route
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii+route
40 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LTABLET, COATED / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii+route
40 equally ranked IID candidates
POLYETHYLENE GLYCOL 600POLYETHYLENE GLYCOL 600NL4J9F21N9TABLET, EXTENDED RELEASE / ORAL2.5 mgExact identifier — unii+route
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii+route
40 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii+route
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii+route
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii+route
40 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii+route
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii+route
40 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, COATED PELLETS / ORAL65 mgExact identifier — unii+route
46 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii+route
40 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii+route
46 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route
40 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
Sanaflu XtraACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGRANDALL DISTRIBUTING, LLC4af8a566-5251-4d46-8692-87a3a07483342025-10-28WarningsExact identifier
ndc (package): 48201-001-12
ndc (product): 48201-001
ndc11 (package): 48201000112
spl id: 42404180-fa1a-fcf6-e063-6394a90a281f
spl set id: 4af8a566-5251-4d46-8692-87a3a0748334

Reported adverse events (FAERS/openFDA)#

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