RxNorm Names
Review RxNorm Normal Forms
SINUS HEADACHE PE
(acetaminophen and phenylephrine hcl)
tablet
[SUPERVALU INC.]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d0b3e727-08ed-4e9b-8301-126095c122b0| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph not final |
Warnings
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
- diabetes
- 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.
Directions
-
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.
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 acid
Principal Display Panel
equaline
compare to the active ingredients in Sudafed PE® Pressure + Pain*
NDC 41163-502-08
non-drowsy, maximum strength
sinus headache PE
acetaminophen and phenylephrine HCl
pain reliever, nasal decongestant
• sinus pain & headache
• sinus pressure
• nasal & sinus congestion
pseudoephedrine free
24 caplets
DOES NOT CONTAIN GLUTEN
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Pressure + Pain.
50844 REV0410B50208
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 equaline 44-502
| SINUS HEADACHE PE
acetaminophen and phenylephrine hcl tablet |
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| 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) | |
