COLTALIN-ND- acetaminophen, phenylephrine hydrochloride tablet
FORTUNE PHARMACAL COMPANY LIMITED
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Uses
■ temporarily relieves these symptoms due to a cold, the flu, or hay fever:
■ minor aches and pains
■ sore throat
■ headache
■ sinus congestion and pressure
■ nasal congestion
■ temporarily reduces fever
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.
for fever for more than 3 days, unless directed by a physician
■ 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
■ difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if the user is
■ taking the blood thinning drug warfarin
■ taking a prescription drug and you do not know if it contains an MAOI
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 is severe
■ sore throat persists for more than 2 days
■ sore throat is accompanied or followed by:
■ fever
■ headache
■ rash
■ nausea
■ vomiting
■ nervousness, dizziness, or sleeplessness occur
■ fever gets worse or lasts more than 3 days
■ any of the following occurs (these could be signs of a serious condition):
■ new symptoms occur
■ pain or fever persist or gets worse
■ redness or swelling is present
Do not give to children under 6 years of age unless directed by a doctor.
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 children even if you do not notice any signs or symptoms.
Directions
■ adults and children 12 years of age and over: 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: 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 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, FDC red no. 40 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-ND
Non-Drowsy
Safely Sealed
NDC 51467-008-01
Acetaminophen - Pain Reliever-Fever Reducer
Phenylephrine Hydrochloride - Nasal Decongestant
Cold, Flu & Hay Fever Multi-Symptom Relief
■ Minor Aches & Pain, Sore Throat
■ Headache, Fever
■ Nasal Congestion, Sinus Pressure/Drainage
24 Tablets
In Individually Sealed Strip
Aspirin Free
COLTALIN-ND
Non-Drowsy
Safely Sealed
NDC 51467-008-02
Acetaminophen - Pain Reliever-Fever Reducer
Phenylephrine Hydrochloride - Nasal Decongestant
Cold, Flu & Hay Fever Multi-Symptom Relief
■ Minor Aches & Pain, Sore Throat
■ Headache, Fever
■ Nasal Congestion, Sinus Pressure/Drainage
36 Tablets
In Individually Sealed Strip
Aspirin Free
COLTALIN-ND
acetaminophen, phenylephrine hydrochloride tablet |
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Labeler - FORTUNE PHARMACAL COMPANY LIMITED (686280561) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
FORTUNE PHARMACAL COMPANY LIMITED | 686280561 | manufacture(51467-008) |