COLTALIN
Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg, CHLORPHENIRAMINE MALEATE 2mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: FORTUNE PHARMACAL COMPANY LIMITED
NDC code: 51467-005
Medically reviewed by Drugs.com. Last updated on Aug 2, 2024.
Active ingredients (in each tablet)
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine hydrochloride 5 mg
Purposes
Pain reliever-fever reducer
Antihistamine
Nasal decongestant
Uses
■ temporarily relieves these symptoms due to a cold, the flu, or hay fever:
■ minor aches and pains
■ sore throat
■ headache
■ runny nose
■ sinus congestion and pressure
■ nasal congestion due to a cold or hay fever
■ runny nose
■ sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever
■ temporarily reduces fever
■ promotes nasal and/or sinus drainage
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if:
■ adult takes more than 12 tablets in 24 hours, which the maximum daily amount for this product
■ child takes more than 5 doses in 24 hours
■ taken with other drugs containing acetaminophen
■ adult has 3 or more alcoholic drinks everyday while using this product
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 whether a prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if the user has
■ heart disease
■ high blood pressure
■ diabetes
■ glaucoma
■ liver disease
■ thyroid disease
■ a high fever
■ a breathing problem such as emphysema or chronic bronchitis
■ difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if the user is
■ taking tranquilizers or sedatives
■ taking the blood thinning drug warfarin
When using this product
■ do not exceed recommended dosage
■ may cause excitability especially in children
■ use caution when driving or operating machinery
■ avoid alcoholic beverages
■ may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect
Stop use and ask a doctor if
■ pain or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)
■ sore throat persists for more than 2 days
■ fever gets worse or lasts more than 3 days
■ nasal congestion is accompanied by fever
■ nervousness, dizziness, or sleeplessness occur
■ redness or swelling is present
■ new symptoms occur
■ any of the following occurs (these could be signs of a serious condition):
■ severe sore throat
■ sore throat is accompanied or followed by fever, headache, rash, nausea or vomiting
Do not give to children under 6 years of age unless directed by a doctor.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
■ adults and children 12 years of age and over: take 2 tablets every 4 hours, while symptoms persist, not to exceed 6 doses (12 tablets) in 24 hours, or as directed by a doctor
■ children 6 to under 12 years of age: take 1 tablet every 4 hours, while symptoms persist, not to exceed 5 doses (5 tablets) in 24 hours, or as directed by a doctor
■ children under 6 years of age : consult a doctor
Other information
■ keep tightly sealed
■ store between below 25 C (77 F) in a dry place, away from direct sunlight
Inactive ingredients colloidal silicon dioxide, corn starch, FD&C yellow no. 6 aluminum lake, magnesium stearate, povidone K30, sodium starch glycolate
Questions or comments? (888) 221-3496 M-F 9 am to 5 pm
■ you may also report serious side effects to this phone number
COLTALIN
Safely Sealed
NDC 51467-005-01
Acetaminophen - Pain Reliever-Fever Reducer
Chlorpheniramine maleate - Antihistamine
Phenylephrine hydrochloride - Nasal Decongestant
Cold, Flu & Hay Fever Multi-Symptom Relief
■ Minor Aches & Pain, Sore Throat
■ Headache, Fever
■ Nasal Congestion, Sinus Pressure/Drainage
■ Sneezing, Runny Nose
■ Itchy, Watery Eyes
24 Tablets
In Individually Sealed Strip
COLTALIN
Safely Sealed
NDC 51467-005-02
Acetaminophen - Pain Reliever-Fever Reducer
Chlorpheniramine maleate - Antihistamine
Phenylephrine hydrochloride - Nasal Decongestant
Cold, Flu & Hay Fever Multi-Symptom Relief
■ Minor Aches & Pain, Sore Throat
■ Headache, Fever
■ Nasal Congestion, Sinus Pressure/Drainage
■ Sneezing, Runny Nose
■ Itchy, Watery Eyes
36 Tablets
In Individually Sealed Strip
COLTALIN
acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride tablet |
|||||||||||||||||||
|
|||||||||||||||||||
|
|||||||||||||||||||
|
|||||||||||||||||||
|
|||||||||||||||||||
|
|||||||||||||||||||
|
Labeler - FORTUNE PHARMACAL COMPANY LIMITED (686280561) |
Registrant - FORTUNE PHARMACAL COMPANY LIMITED (686280561) |
Establishment | |||
Name | Address | ID/FEI | Operations |
FORTUNE PHARMACAL COMPANY LIMITED | 686280561 | manufacture(51467-005) |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
See also:
Wegovy
Wegovy (semaglutide) an FDA-approved weekly injection for weight loss and to reduce heart risks ...
Rybelsus
Rybelsus tablets are used to improve blood sugar control in adults with type 2 diabetes, and may ...
Ozempic
Learn about Ozempic (semaglutide) for type 2 diabetes treatment, weight management, cardiovascular ...
Zepbound
Zepbound (tirzepatide) is an FDA-approved weekly injection for weight loss and obstructive sleep ...
Trulicity
Trulicity is an injectable diabetes medicine that is used together with diet and exercise to ...
Lantus
Lantus is a long acting form of insulin used to treat type 1 or type 2 diabetes. Learn about side ...
Tresiba
Tresiba (insulin degludec) is used to treat diabetes mellitus. Includes Tresiba side effects ...
Victoza
Victoza helps control blood sugar levels and reduce the risk of serious heart problems in people ...
Levemir
Levemir (insulin detemir) is a long acting insulin used to treat diabetes in adults and children ...