Rite Aid 44-546-delisted
Drug Labeling and Warnings
Drug Details [pdf]
COLD AND COUGH SINUS RELIEF PE NON-DROWSY- acetaminophen, dextromethorphan hbr, guaifenesin, 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 44-546-delisted
Active ingredients (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 100 mg
Phenylephrine HCl 5 mg
Uses
- temporarily relieves these symptoms due to the common cold:
- nasal congestion
- headache
- minor aches and pains
- cough
- sore throat
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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.
- 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, cough, 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
- persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache
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 (1-800-222-1222) 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 years and over
- take 2 caplets every 4 hours
- do not take more than 10 caplets in 24 hours
- children under 12 years: ask a doctor
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 or lot number
Inactive ingredients
corn starch, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, talc, titanium dioxide
Principal Display Panel
RITE AID®
PHARMACY
*Compare to the active ingredients in SUDAFED PE® PRESSURE + PAIN + COLD
cold & cough
sinus relief PE
acetaminophen 325 mg, dextromethorphan HBr 10 mg
guaifenesin 100 mg, phenylephrine HCl 5 mg
pain reliever/fever reducer, cough suppressant
expectorant & nasal decongestant
NON-DROWSY
relieves:
sore throat, head and body aches
sinus pressure and congestion
cough and chest congestion
20 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 by or distributed by McNeil Consumer Healthcare, owner of the registered trademark SUDAFED PE® PRESSURE + PAIN + COLD.
50844 REV0314B54609
DISTRIBUTED BY:
RITE AID
30 HUNTER LANE,
CAMP HILL, PA 17011
SATISFACTION GUARANTEE IF YOU'RE NOT SATISFIED, WE'LL HAPPILY REFUND YOUR MONEY.
Rite Aid 44-546
| COLD AND COUGH SINUS RELIEF PE
NON-DROWSY
acetaminophen, dextromethorphan hbr, guaifenesin, 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(11822-0546) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867837 | PACK(11822-0546) | |