SanaTos Severe Cold and Cough Nighttime

Pharmadel LLC

SanaTos Severe Cold and Cough Nighttime

FULL PRESCRIBING INFORMATION: CONTENTS*

• SanaTos Severe Cold and Cough Nighttime Uses
• Warnings
  • Liver warning
  • Sore throat warning
• Age Dose
• Directions
• SanaTos Severe Cold and Cough Nighttime Other information
• Inactive ingredients
• Questions or Comments?
• PRINCIPAL DISPLAY PANEL - 6 Packet Carton

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

SanaTos Severe Cold and Cough Nighttime Uses

• Temporarily relieves these symptoms due to a cold:
  • minor aches and pains
  • minor sore throat pain
  • headache
  • nasal and sinus congestion
  • 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

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

• more than 6 packets in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Sore throat warning

if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do Not Use

• to make a chid sleepy
• if you are allergic to acetaminophen
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• with any other product containing diphenhydramine, even one used on skin
• 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.

Ask a doctor before use if you have

• high blood pressure
• liver disease
• heart disease
• thyroid disease
• trouble urinating due to an enlarged prostate gland
• glaucoma
• a sodium-restricted diet
• diabetes
• cough that occurs with too much phlegm (mucus)
• a breathing problem such as emphysema, asthma or chronic bronchitis
• cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

When using this product

• do not use more than directed
• avoid alcoholic drinks
• marked drowsiness may occur
• alcohol, sedatives and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask doctor if

• new symptoms occur
• you get nervous, dizzy, or sleepless
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• pain, cough or nasal congestion gets worse or lasts more than 7 days
• cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

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. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Age Dose

Children under 4 years of age – Do not use
Children 4 to under 12 years of age – Do not use unless directed by a doctor
Adults and children 12 years of age and over – One packet

Directions

• do not use more than directed
• take every 4 hours; do not take more than 6 packets in 24 hours unless directed by a doctor
• dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.
• if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.

SanaTos Severe Cold and Cough Nighttime Other information

• each packet contains: potassium 10 mg, sodium 23 mg
• phenylketonurics: contains phenylalanine 13 mg per packet
• store at controlled room temperature 20-25 degrees C (68-77 degrees F). Protect from excessive heat and moisture.

Inactive ingredients

acesulfame K, aspartame, citric acid, D&C yellow #10, FD&C blue #1, FD&C red #40, flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate

Questions or Comments?

Call 877-393-9405

Distributed by:
PHARMADEL
Seaford, DE 19973

PRINCIPAL DISPLAY PANEL - 6 Packet Carton

NDC# 55758-009-06

SanaTos^®

Severe COLD & COUGH

• Acetaminophen • Diphenhydramine
• Phenylephrine

Nighttime

• Nasal Congestion
• Cough
• Sore Throat
• Runny Nose
• Sneezing
• Headache
• Fever
• Body Ache

Lemon & Honey Flavored 6 Packets