Label: FEDRIN- acetaminophen, phenylephrine tablet
- NDC Code(s): 51532-0140-2
- Packager: Afassco Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated November 28, 2016
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- ACTIVE INGREDIENT
Active Ingredients (In Each Tablet)
Acetaminophen 500 mg, Phenylephrine HCl 5 mgClose
Pain reliever/fever reducer, Nasal decongestantClose
- INDICATIONS & USAGE
For temporary relief of nasal congestion associated with sinusitis.
Temporarily relieves headache and sinus pain.Close
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours, if you take with other drugs containing acetaminophen (prescription or nonprescription), or if you have 3 or more alcoholic drinks every day while using this product.Close
- ASK DOCTOR
Ask a doctor before use if you have: heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to an enlarged prostate gland, cough that occurs with too much phlegm (mucus), chronic cough that lasts such as occurs with smoking, asthma, or emphysema or chronic bronchitis.Close
- STOP USE
Stop use and ask a doctor if: you get nervous, dizzy or sleepless, cough lasts more than 7 days, comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.Close
- PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health care professional before use.Close
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.Close
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.Close
- DOSAGE & ADMINISTRATION
Directions: Do not use more than directed.
Adults and children: (12 years and older) Take 2 tablets with water every 6 hours as needed. Do not take more than 8 tablets in 24 hours, or as directed by doctor.
Children: (under 12 years)
Do use unless directed by a doctor.Close
- INACTIVE INGREDIENT
SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATIONClose
- INGREDIENTS AND APPEARANCE
acetaminophen, phenylephrine tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51532-0140 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) POVIDONE (UNII: FZ989GH94E) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color blue Score no score Shape ROUND Size 12mm Flavor Imprint Code FR33 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51532-0140-2 2 in 1 PACKET; Type 0: Not a Combination Product 10/25/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/25/2016 Labeler - Afassco Inc. (609982723)