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Acetaminophen, Phenylephrine Hydrochloride
Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: AAA Pharmaceutical, Inc.
NDC code: 57344-120
Drug Facts
| Active ingredients (in each caplet) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Phenylephrine HCl 5 mg | Nasal decongestant |
- temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
- sinus congestion and pressure
- headache
- minor aches and pains
- nasal congestion
- promotes sinus drainage
- temporarily reduces fever
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
- 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
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
When using this product do not exceed recommended dosage
- 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.
If pregnant or breast-feeding, ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- do not take more than directed (see overdose warning)
| adults and children 12 years and over |
|
| children under 12 years |
|
- store between 20-25ºC (68-77ºF) in a dry place
- retain carton for complete product information
colloidal silicon dioxide, croscarmellose sodium, FD&C yellow #6, hypromellose, lactose, magnesium stearate, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate, stearic acid, titanium dioxide, triacetin
Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048
RESTORE u
NDC 57344-120-06
†COMPARE TO THE ACTIVE
INGREDIENTS IN SUDAFED PE
®
PRESSURE + PAIN
MAXIMUM
STRENGTH
NON-DROWSY
Pressure & Pain PE
For Adults
Acetaminophen, Phenylephrine HCl
Pain Reliever/Fever Reducer, Nasal Decongestant
Relieves: • Sinus Headache • Sinus Pressure
• Sinus Congestion
FORMERLY
SINUS HEADACHE PE
24 CAPLETS
| ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
acetaminophen and phenylephrine hydrochloride tablet, coated |
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| Labeler - AAA Pharmaceutical, Inc. (181192162) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| AAA Pharmaceutical, Inc. | 080164679 | manufacture(57344-120) | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| AAA Pharmaceutical, Inc. | 181192162 | pack(57344-120) | |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.