Label: SANAFLU XTRA- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, gelatin coated
- NDC Code(s): 48201-001-12
- Packager: GRANDALL DISTRIBUTING, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 23, 2024
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- Official Label (Printer Friendly)
- Active ingredients (in each capsule)
- Purposes
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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
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Warnings
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
- 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.
- Directions
- Other information
- Inactive ingredients
- Package Labeling
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INGREDIENTS AND APPEARANCE
SANAFLU XTRA
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, gelatin coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48201-001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength 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 Color blue (transparent blue) Score no score Shape OVAL (oblong) Size 24mm Flavor Imprint Code none Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48201-001-12 12 in 1 BOX; Type 0: Not a Combination Product 04/30/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 04/30/2015 Labeler - GRANDALL DISTRIBUTING, LLC (044428324)
