FDA Label for Relief-pe
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR/PHARMACIST
- OTC - ASK DOCTOR
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Relief-pe Product Label
The following document was submitted to the FDA by the labeler of this product Hart Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredients (in each tablet):
Acetaminophen 325mg
Phenylephrine HCl 5mg
Chlorpheniramine Maleate 2mg
Otc - Purpose
Purpose:
Pain Reliever/Fever Reducer
Antihistamine
Nasal Decongestant
Indications & Usage
Temporarily relieves nasal congestion, sinus pressure, and minor aches and pains due to:
- the common cold
- hay fever
- upper respiratory allergies
- headache
- itchy/watery eyes
- runny nose
- muscular aches
Temporarily reduces fever
Warnings
Liver warning: this product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4000mg of acetaminophen 24 hours
- with other drugs containing acetaminophen
- 3 or more alcohol drinks every day while using this product
- skin reddening
- blisters
- rash
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
Otc - Do Not Use
Do not use:
- with any other drug containing acetaminophen (prescription or non-prescription)
- 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, or if you do not know if your prescription drug contains an MAOI
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if
- you are taking sedatives or tranquilizers
- you are taking the blood thinning drug warfarin
- you do not know if other drugs you are taking contain acetaminophen
Otc - Ask Doctor
Ask a doctor before use if you have
- heart, liver, or thyroid disease
- high blood pressure
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Otc - When Using
When using this product to not use more than directed. This product may cause excitability or drowsiness. Alcohol, sedatives and tranquilizers may increase the drowsiness effect. Use caution when driving a motor vehicle or operating machinery.
Otc - Stop Use
Stop use and ask a doctor if
- an allergic reaction occurs, seek medical help right away
- you get nervous, dizzy or sleepless
- new symptom occur
- fever worsens or lasts for more than 3 days
- pain or nasal congestion gets worse or lasts more than 7 days
- redness or swelling is present
These could be signs of serious condition
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
Overdose warning:
Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222.
Dosage & Administration
Directions: Do not take more than directed. Adults and children 12 years of age an over:
- take 1 to 2 tablets every 6 hours while symptoms persist
- do not take more than 8 tablets in 24 hours unless directed by a doctor
Children under 12 years of age: ask a doctor
Inactive Ingredient
corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelantined starch, stearic acid
Package Label.Principal Display Panel
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