BACZOL COLD (Lex)
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 5 mL tsp.)Acetaminophen 250 mg Dextromethorphan HBr 10 mg Chlorpheniramine Maleate 4 mg Phenylephrine HCl 10 mg
OTC - PURPOSE SECTION
PurposeAcetaminophen .................... Analgesic and Antipyretic Dextromethorphan HBr ....................Cough Suppressant Chlorpheniramine Maleate .........................Antihistamine Phenylephrine HCl ........................ Nasal Decongestant
INDICATIONS & USAGE SECTION
Uses • Temporarily relieves runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever • nasal congestion due to the common cold • Calms the cough control center and relieves coughing • minor aches and pains associated with the common cold • temporarily reduces fever.
WARNINGS SECTION
Warnings: Liver warning: This product containsacetaminophen• Severe liver damage may occur if • adult takes more than 6 doses in 24 hours, which is the maximum daily amount •child takes more than 6 doses in 24 hours • taken with other drugs containing acetaminophen• adult has 3 or more alcoholic drinks every day while using this product • Do not give to children under 3 years of age or use for more than 10 days unless directed by a physician.
SPL UNCLASSIFIED SECTION
Stop Use and ask a Doctor if • you have liver disease • pain, cough or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • you have a breathing problem such as emphysema or chronic bronchitis • you have glaucoma or difficulty in urination due to enlargement of the prostate gland • you have shortness of breath, asthma, heart disease, high blood pressure, thyroid disease, diabetes.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a Doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
OTC - WHEN USING SECTION
When using this product, do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. May cause excitability especially in children. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving motor vehicle or operating machinery.
PRECAUTIONS SECTION
Precaution: this product contains FD&C Yellow #5 (Tartrazine) as color additive.
OTC - DO NOT USE SECTION
Do Not Use: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 • 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 allergic to acetaminophen or any of the inactive ingredients in the product • for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor • if you are taking sedatives or tranquilizers, without first consulting your 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.
OVERDOSAGE SECTION
Overdose Warning: taking more than recommended dose (overdose) may cause liver damage. In case of accidental overdose, contact a physician or 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 Do not exceed more than 6 doses for children and adults in a 24 - hour period.
| Adults and Children 12 years of age and over | 1 teaspoon (5 mL) every 4 hours |
| Children 6 to under 12 years of age | 1/2 teaspoon (2.5 mL) every 4 hours |
| Children under 6 years of age | Ask a doctor |
OTHER SAFETY INFORMATION
Other information • Store at room temperature 15º-30ºC (59º-86ºF). Tamper evident: Do not use if there is evidence of tampering.
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENT SECTION
Inactive ingredients Banana Flavor, cherry flavor, FD&C yellow #5, glycerin, methyl paraben (as preservative), polyethylene glycol 400, propyl paraben (as preservative), purified water, sucralose and Xanthan gum.
OTC - QUESTIONS SECTION
Questions or comments?customer.service@lablopez.com.sv 754-260-6479
Product Labeling
NDC 76864-208-01
Baczol ®COLD MEDICINE
Acetaminophen • Analgesic and Antipyretic Dextromethorphan HBr • Cough Suppressant Chlorpheniramine Maleate • Antihistamine Phenylephrine HCl • Nasal Decongestant
Fruit Flavor
For sale in theUS only.
SHAKE WELLBEFORE USE
• Sugar FREE • Alcohol FREE
4 fl.oz. (120 mL)
Manufactured For: Laboratorios López, S.A. de C.V.Boulevard del Ejército Nacional, Km. 5 1/2, Soyapango, San Salvador, El Salvador, C.A.
Baczol ® is registered trademark of Laboratorios López, S.A. de C.V.
7 69041 04544 8
Lot: Rev. 05/2020
Exp. Date:
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