FDA Label for Acetaminophen Solution
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH 5 ML)
- PURPOSE
- USES
- LIVER WARNING
- ALLERGY
- SORE THROAT
- DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL - 5 ML CUP LABEL
- PRINCIPAL DISPLAY PANEL - 10.15 ML CUP LABEL
- PRINCIPAL DISPLAY PANEL - 20.3 ML CUP LABEL
Acetaminophen Solution Product Label
The following document was submitted to the FDA by the labeler of this product Patrin Pharma, Inc.. 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
Patrin Pharma
Skokie, IL 60076
www.patrinpharma.com
Rev 02.0424
Active Ingredient (In Each 5 Ml)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Uses
Temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- backache
- minor pain of arthritis
- the common cold
- toothache
- premenstrual and menstrual cramps
Temporarily reduces fever
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if:
- an adult takes more than 6 doses in 24 hours, or greater than 4000 mg of acetaminophen, the maximum daily amount
- a child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- taken with 3 or more alcoholic drinks every day while using this product
Allergy
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
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
- for more than 10 days for pain unless directed by a doctor
- for more than 3 days for fever unless directed by a doctor
- if you are allergic to acetaminophen or any of the inactive ingredients of his product
Otc - Ask Doctor
Ask a doctor before use if you have liver disease.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Stop Use And Ask A Doctor If
- symptoms do not improve
- new symptoms occur
- pain or fever persists or gets worse
- redness or swelling is present
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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 right away. (1-800-222-1222). Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Directions
- Do not take more than directed (see overdose warning)
- Use the following dosage guidelines when using this product
| AGE | DOSE |
|---|---|
| Adults and children 12 years of age and over | 20.3 mL (650 mg) every 4 to 6 hours Not to exceed 6 doses in a 24-hour period |
| Children 6 to under 12 years of age | 10.15 mL (325 mg) every 4 hours Not to exceed 5 doses in a 24-hour period |
| Children 4 to under 6 years of age | 7.5 mL (240 mg) every 4 hours Not to exceed 5 doses in a 24-hour period |
| Children 2 to under 4 years of age | 5 mL (160 mg) every 4 hours Not to exceed 5 doses in a 24-hour period |
| Children under 2 years of age | Consult a doctor |
Other Information
- Each 5 mL contains: sodium 2 mg
- Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
- Keep tightly closed
- Protect from light
- Do not use if foil on cup is missing or torn
Inactive Ingredients
Citric acid, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, and sorbitol.
Questions Or Comments?
Call (800) 936-3088. You may also report serious side effects to this phone number.
How Supplied
- A red, cherry flavored solution supplied in the following oral dosage cups:
| NDC 39328-031-05: | 5 mL unit dose cup |
| NDC 39328-031-50: | Case contains 50 unit dose cups of 5 mL (39328-031-05). |
| NDC 39328-031-99: | Case contains 100 unit dose cups of 5 mL (39328-031-05). |
| NDC 39328-032-10: | 10.15 mL unit dose cup |
| NDC 39328-032-50: | Case contains 50 unit dose cups of 10.15 mL (39328-032-10). |
| NDC 39328-032-99: | Case contains 100 unit dose cups of 10.15 mL (39328-032-10). |
| NDC 39328-034-20: | 20.3 mL unit dose cup |
| NDC 39328-034-50: | Case contains 50 unit dose cups of 20.3 mL (39328-034-20). |
| NDC 39328-034-99: | Case contains 100 unit dose cups of 20.3 mL (39328-034-20). |
Principal Display Panel - 5 Ml Cup Label
Delivers 5 mL
NDC 39328-031-05
Acetaminophen
Oral Solution USP
160 mg/5 mL
Alcohol Free
For Institutional Use Only
See Insert
Lot# xxxxxx
Exp: yyyy/mm/dd
Patrin Pharma
Skokie, IL 60076
Rev 03.0324
Principal Display Panel - 10.15 Ml Cup Label
Delivers 10.15 mL
NDC 39328-032-10
Acetaminophen
Oral Solution USP
325 mg/10.15 mL
Alcohol Free
For Institutional Use Only
See Insert
Lot# xxxxxx
Exp: yyyy/mm/dd
Patrin Pharma
Skokie, IL 60076
Rev 03.0324
Principal Display Panel - 20.3 Ml Cup Label
Delivers 20.3 mL
NDC 39328-034-20
Acetaminophen
Oral Solution USP
650 mg/20.3 mL
Alcohol Free
For Institutional Use Only
See Insert
Lot# xxxxxx
Exp: yyyy/mm/dd
Patrin Pharma
Skokie, IL 60076
Rev 03.0324
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