FDA Label for Ampigrin Ultra Forte Night
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- LIVER WARNING
- ALLERGY ALERT
- SORE THROAT WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
Ampigrin Ultra Forte Night Product Label
The following document was submitted to the FDA by the labeler of this product Opmx Llc. 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.
Other
Drug Facts
Made for:
RRX
Exclusively distributed by:
OPMX
Chula Vista, CA 91910
Otc - Purpose
Active ingredients (in each Softgels) | Purpose |
---|---|
Acetaminophen 325 mg | Pain reliever/fever reducer |
Dextromethorphan HBr 15 mg | Cough suppressant |
Doxylamine succinate 6.25 mg | Antihistamine |
Uses
Temporarily relieves common cold/flu symptoms:
- Cough due to minor throat & bronchial irritation
- Sore throat
- Headache
- Minor aches & pains
- Fever
- Runny nose & sneezing
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hrs, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Allergy Alert
Acetaminophen may cause severe skin reactions. Symptoms may include:
• skin reddening • blisters • rash • If a skin reaction occurs, stop use and seek medical help right away
Sore Throat Warning
If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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.
Ask A Doctor Before Use If You Have
- liver disease
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
- trouble urinating due to enlarged prostate gland
When Using This Product
- Excitability may occur, especially in children
- Marked drowsiness may occur
- Avoid Alcoholic drinks
- Be careful when driving a motor vehicle or operating machinery
- Alcohol, sedatives, & tranquilizers may increase drowsiness
Stop Use And Ask A Doctor If
- Pain 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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose Warning
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.
Directions
- Take only as directed
- Do not exceed 4 doses per 24 hrs
Adults & children 12 yrs & over | 2 softgels with water every 6 hrs |
Children 4 to under 12 yrs | Ask a doctor |
Children under 4 yrs | Do not use |
Other Information
- Store at room temperature
Inactive Ingredients
D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide
Questions?
Call toll free 619-600-5632 Monday through Friday 9AM - 5PM EST
Principal Display Panel
NDC 69729-003-10
Ampigrin Ultra Forte
Acetaminophen 325 mg Pain Reliever/Fever Reducer
Dextromethorphan HBr 15 mg, Cough suppressant
Doxylamine Succinate 6.25 mg Antihistamine
COLD & COUGH
- Cough Suppressant
- Expectorant
- Nasal Congestion
- Sneezing
- Itchy, Watery Eyes & Runny Nose
- Descongestionante de las vías Respiratorias
- Congestión Nasal
- Estornudos
- Comezon, Ojos llorosos y Escurrimiento Nasal
10 Softgels
* Please review the disclaimer below.