Equaline 44-502-Delisted
Drug Labeling and Warnings
Drug Details [pdf]
SINUS HEADACHE PE- acetaminophen and phenylephrine hcl tablet
SUPERVALU INC.
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.
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Equaline 44-502-Delisted
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) | |