Label: SUDAFED PE HEAD CONGESTION PLUS FLU SEVERE- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, film coated
- NDC Code(s): 50580-450-01
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 8, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
Warnings
Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg acetaminophen) in 24 hours. 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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 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
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- 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.
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Directions
- do not use more than directed (see overdose warning)
adults and children 12 years and over - take 2 tablets every 4 hours
- do not take more than 10 tablets in 24 hours
children under 12 years ask a doctor - Other information
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL
PREVIOUSLY SUDAFED PE ® PRESSURE + PAIN + COLD
NDC 50580-450-01SUDAFED PE®
HEAD CONGESTION
+ FLU SEVEREAcetaminophen, Dextromethorphan HBr, Guaifenesin,
Phenylephrine HCl, Pain Reliever/Fever Reducer,
Cough Suppressant, Expectorant, Nasal Decongestantactual
size- SINUS PRESSURE
- HEADACHE
- SORE THROAT
- COUGH
- CHEST CONGESTION
24 TABLETS
NON-DROWSY
-
INGREDIENTS AND APPEARANCE
SUDAFED PE HEAD CONGESTION PLUS FLU SEVERE
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-450 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) ALUMINUM OXIDE (UNII: LMI26O6933) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARNAUBA WAX (UNII: R12CBM0EIZ) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Product Characteristics Color orange Score no score Shape OVAL Size 19mm Flavor Imprint Code SUPE;WL92 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-450-01 2 in 1 CARTON 06/17/2019 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/17/2019 Labeler - Johnson & Johnson Consumer Inc. (878046358)