SEVERE COLD AND SINUS RELIEF PE- acetaminophen, diphenhydramine hcl and phenylephrine hcl tablet, film coated
Rite Aid Corporation
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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Rite Aid 44-526-Delisted
Active ingredients (in each caplet)
Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg
Uses
- temporarily relieves these symptoms due to the common cold:
- sneezing
- minor aches and pains
- nasal congestion
- headache
- sore throat
- cough
- runny nose
- temporarily reduces fever
- temporarily relieves sinus congestion and pressure
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg 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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- blisters
- rash
- skin reddening
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
- with any other product containing diphenhydramine, even one used on skin
- 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
- thyroid disease
- heart disease
- diabetes
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- cough accompanied by too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- high blood pressure
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough 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.
Directions
-
do not use more than directed
- adults and children 12 years and over
- take 2 caplets every 4 hours
- do not take more than 10 caplets in 24 hours
- children under 12 years: do not use
Other information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- 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, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, talc, titanium dioxide
Principal Display Panel
RITE AID®
PHARMACY
*Compare to the active ingredients in Sudafed PE® Severe Cold
severe cold &
sinus relief PE
acetaminophen 325 mg
diphenhydramine HCl 12.5 mg, phenylephrine HCl 5 mg
pain reliever/fever reducer, antihistamine,
cough suppressant & nasal decongestant
relieves:
sore throat, fever, head and body aches
sinus pressure and congestion
cough, runny nose and sneezing
24 CAPLETS
ACTUAL
SIZE
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the
registered trademark Sudafed PE® Severe Cold. 50844 REV0616B52608
DISTRIBUTED BY: RITE AID
30 HUNTER LANE, CAMP HILL, PA 17011
IF YOU'RE NOT SATISFIED, WE'LL Rite Aid 44-526
HAPPILY REFUND YOUR MONEY.
| SEVERE COLD AND SINUS RELIEF PE
acetaminophen, diphenhydramine hcl and phenylephrine hcl tablet, film coated |
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| Labeler - Rite Aid Corporation (014578892) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | MANUFACTURE(11822-5260) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867837 | PACK(11822-5260) | |