DOSAGE & ADMINISTRATION SECTION.

Directions. do not use more than directeddo not take more than 10 chewable tablets in 24 hours unless directed by doctor. Take every hours, while symptoms persist.AgeDoseadults and children 12 years of age and overtake chewable tablets every hourschildren under 12 years of agedo not use. do not use more than directed. do not take more than 10 chewable tablets in 24 hours unless directed by doctor. Take every hours, while symptoms persist.

INACTIVE INGREDIENT SECTION.

Inactive ingredients. brown iron oxide, calcium gluconate monohydrate, carboxymethylcellulose calcium, carnauba wax, corn syrup solids, crospovidone, FD&C red no. 40, glycerin, mannitol, natural and artificial flavors, pregelatinized starch, simethicone, sodium gluconate, sorbitol, sorbitol solution, sucralose, sucrose, whole dry milk.

INDICATIONS & USAGE SECTION.

Uses. temporarily relieves these symptoms due to cold: minor aches and painssore throat painheadacherunny nosesneezingitchy nose or throatitchy, watery eyes due to hay fevercough due to minor throat and bronchial irritation temporarily reduces fever. temporarily relieves these symptoms due to cold: minor aches and painssore throat painheadacherunny nosesneezingitchy nose or throatitchy, watery eyes due to hay fevercough due to minor throat and bronchial irritation minor aches and pains. sore throat pain. headache. runny nose. sneezing. itchy nose or throat. itchy, watery eyes due to hay fever. cough due to minor throat and bronchial irritation. temporarily reduces fever.

OTC - ACTIVE INGREDIENT SECTION.

Active ingredients (in each chewable tablet). Acetaminophen 325 mgDiphenhydramine HCl 12.5 mg.

OTC - ASK DOCTOR SECTION.

Ask doctor before use if you have. liver diseaseglaucomatrouble urinating due to an enlarged prostate glanda breathing problem such as emphysema or chronic bronchitiscough that occurs with too much phlegm (mucus)cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. liver disease. glaucoma. trouble urinating due to an enlarged prostate gland. breathing problem such as emphysema or chronic bronchitis. cough that occurs with too much phlegm (mucus). cough that lasts or is chronic such as occurs with smoking, asthma or emphysema.

OTC - ASK DOCTOR/PHARMACIST SECTION.

Ask doctor or pharmacist before use if you are. taking sedatives or tranquilizerstaking the blood thinning drug warfarin. taking sedatives or tranquilizers. taking the blood thinning drug warfarin.

OTC - DO NOT USE SECTION.

Do not use. in child under 12 years of ageif you are allergic to acetaminophenwith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.with any other product containing diphenhydramine, even one used on the skin. in child under 12 years of age. if you are allergic to acetaminophen. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.. with any other product containing diphenhydramine, even one used on the skin.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.

Keep out of reach of children.. In case of overdose, get medical help or contact 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION.

If pregnant or breast-feeding,. ask health professional before use.

OTC - PURPOSE SECTION.

Purposes. Pain reliever/Fever reducerAntihistamine/Cough suppressant.

OTC - QUESTIONS SECTION.

Questionsor comments. call 1-855-328-5259.

OTC - STOP USE SECTION.

Stop use and ask doctor if. fever gets worse or lasts more than daysredness or swelling is presentnew symptoms occurpain or cough gets worse or lasts more than dayscough comes back or occurs with rash or headache that lastsThese could be signs of serious condition.. fever gets worse or lasts more than days. redness or swelling is present. new symptoms occur. pain or cough gets worse or lasts more than days. cough comes back or occurs with rash or headache that lasts.

OTC - WHEN USING SECTION.

When using this product. avoid alcoholic drinksmarked drowsiness may occuralcohol, sedatives and tranquilizers may increase drowsinessbe careful when driving motor vehicle or operating machineryexcitability may occur, especially in children. avoid alcoholic drinks. marked drowsiness may occur. alcohol, sedatives and tranquilizers may increase drowsiness. be careful when driving motor vehicle or operating machinery. excitability may occur, especially in children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Package/Label Principal Display Panel. NEWTHERAFLUSEVERE COLD RELIEFNIGHTTIMESoft CHEWS AcetaminophenPain Reliever/Fever ReducerDiphenhydramine HClAntihistamine/Cough SuppressantFASTrelief ANYWHEREfever cough headache body aches sore throat runny nose sneezing watery eyes20 CHEWABLE TABLETSChew tablets completely before swallowingApple Cinnamon Flavor. Theraflu SC Night Soft Chews 20 ct.

SPL UNCLASSIFIED SECTION.

Other information. each chewable tablet contains:calcium 10 mg, potassium 10 mg, sodium, mg store at controlled room temperature 20-25C (68-77F). each chewable tablet contains:calcium 10 mg, potassium 10 mg, sodium, mg store at controlled room temperature 20-25C (68-77F).

WARNINGS SECTION.

Warnings. Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hourswith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this productAllergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddeningblistersrashIf skin reaction occurs, stop use and seek medical help right away.Sore throat warning:If sore throat is severe, persists for more than days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult doctor promptly. more than 4,000 mg of acetaminophen in 24 hours. with other drugs containing acetaminophen. or more alcoholic drinks every day while using this product. skin reddening. blisters. rash. Do not use. in child under 12 years of ageif you are allergic to acetaminophenwith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.with any other product containing diphenhydramine, even one used on the skin. in child under 12 years of age. if you are allergic to acetaminophen. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask doctor or pharmacist.. with any other product containing diphenhydramine, even one used on the skin. Ask doctor before use if you have. liver diseaseglaucomatrouble urinating due to an enlarged prostate glanda breathing problem such as emphysema or chronic bronchitiscough that occurs with too much phlegm (mucus)cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. liver disease. glaucoma. trouble urinating due to an enlarged prostate gland. breathing problem such as emphysema or chronic bronchitis. cough that occurs with too much phlegm (mucus). cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. Ask doctor or pharmacist before use if you are. taking sedatives or tranquilizerstaking the blood thinning drug warfarin. taking sedatives or tranquilizers. taking the blood thinning drug warfarin. When using this product. avoid alcoholic drinksmarked drowsiness may occuralcohol, sedatives and tranquilizers may increase drowsinessbe careful when driving motor vehicle or operating machineryexcitability may occur, especially in children. avoid alcoholic drinks. marked drowsiness may occur. alcohol, sedatives and tranquilizers may increase drowsiness. be careful when driving motor vehicle or operating machinery. excitability may occur, especially in children. Stop use and ask doctor if. fever gets worse or lasts more than daysredness or swelling is presentnew symptoms occurpain or cough gets worse or lasts more than dayscough comes back or occurs with rash or headache that lastsThese could be signs of serious condition.. fever gets worse or lasts more than days. redness or swelling is present. new symptoms occur. pain or cough gets worse or lasts more than days. cough comes back or occurs with rash or headache that lasts. If pregnant or breast-feeding,. ask health professional before use.. Keep out of reach of children.. In case of overdose, get medical help or contact 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.