Label: SINUS HEADACHE PE- acetaminophen and phenylephrine hydrochloride tablet
- NDC Code(s): 41163-502-08
- Packager: SUPERVALU INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated February 25, 2013
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- Active ingredients (in each caplet)
Acetaminophen 325 mgClose
Phenylephrine HCl 5 mg
- temporarily relieves headache, minor aches and pains
- temporarily relieves nasal congestion
Liver warning: This product containsa acetaminophen. Severe liver damage may occur if you take:
- more than 12 caplets in 24 hours, which is the maximum daily amount
- 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 monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping an 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
- trouble urinating due to an enlarged prostate gland
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain 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
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- do not use more than directed
(see overdose warning)
- adults and children 12 ears and over
- take 2 caplets every 4 hours
- do not take more than 12 caplets in 24 hours
- children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
- do not use more than directed
- Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
- Inactive ingredients
corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, silica gel, stearic acidClose
- Questions or comments?
- Principal Display Panel
compare to the active ingredients in Sudafed PE® Pressure + Pain*
non-drowsy, maximum strength
sinus headache PE
acetaminophen and phenylephrine HCl
pain reliever, nasal decongestant
• sinus pain & headache
• sinus pressure
• nasal & sinus congestion
DOES NOT CONTAIN GLUTEN
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Pressure + Pain.
DISTRIBUTED BY SUPERVALU INC.
EDEN PRARITE, MN 55344 USA
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
- INGREDIENTS AND APPEARANCE
SINUS HEADACHE PE
acetaminophen and phenylephrine hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-502 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE (UNII: 68401960MK) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONES (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color ORANGE Score no score Shape CAPSULE Size 17mm Flavor Imprint Code 44;502 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-502-08 1 in 1 CARTON 1 24 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 06/23/2005 Labeler - SUPERVALU INC. (006961411) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(41163-502) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(41163-502)