Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each tablet)Acetaminophen 325 mg Chlorpheniramine maleate 2 mgPhenylephrine hydrochloride 5 mg
OTC - PURPOSE SECTION
PurposesPain reliever-fever reducerAntihistamineNasal decongestant
INDICATIONS & USAGE SECTION
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 SECTION
WarningsLiver 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
OTC - DO NOT USE SECTION
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.
OTC - ASK DOCTOR/PHARMACIST SECTION
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
OTC - WHEN USING SECTION
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
OTC - STOP USE SECTION
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
DOSAGE & ADMINISTRATION SECTION
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 SAFETY INFORMATION
Other information■ keep tightly sealed■ store between below 25 C (77 F) in a dry place, away from direct sunlight
INACTIVE INGREDIENT SECTION
Inactive ingredients colloidal silicon dioxide, corn starch, FD&C yellow no. 6 aluminum lake, magnesium stearate, povidone K30, sodium starch glycolate
OTC - QUESTIONS SECTION
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 ReducerChlorpheniramine maleate - AntihistaminePhenylephrine 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
Aspirin Free
COLTALIN
Safely Sealed
NDC 51467-005-02
Acetaminophen - Pain Reliever-Fever ReducerChlorpheniramine maleate - AntihistaminePhenylephrine 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
Aspirin Free