SANAFLU XTRA- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, gelatin coated 
GRANDALL DISTRIBUTING, LLC

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Grandall (as PLD) - Sanaflu Xtra (48201-001)

Active ingredients (in each capsule)

Acetaminophen 250 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever - fever reducer

Antihistamine

Cough Suppressant

Nasal Decongestant

Uses

Warnings

Liver warningThis product contains acetaminophen. Severe liver damage may occur if you take

Do not use

  • 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

  • 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

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

When using this product

  • 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

  • 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,

ask a health professional before use.

Keep out of reach of children.

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

Other information

Inactive ingredients

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

boxdrug facts panel 1drug facts panel 2

SANAFLU XTRA 
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48201-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorblue (transparent blue) Scoreno score
ShapeOVAL (oblong) Size24mm
FlavorImprint Code none
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48201-001-1212 in 1 BOX; Type 0: Not a Combination Product04/30/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01304/30/2015
Labeler - GRANDALL DISTRIBUTING, LLC (044428324)

Revised: 1/2024
Document Id: 0fa52f88-6046-a274-e063-6294a90ac211
Set id: 4af8a566-5251-4d46-8692-87a3a0748334
Version: 9
Effective Time: 20240123
 
GRANDALL DISTRIBUTING, LLC