FDA Label for Rite Aid Nighttime Severe Cold And Cough Relief

Other

Drug Facts

DISTRIBUTED BY: RITE AID
30 HUNTER LANE, CAMP HILL, PA 17011

Otc - Purpose

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
  
  

Allergy Alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Liver Warning

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

• more than 4,000 mg of acetaminophen in 24 hours
• 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

• in a child under 4 years of age
• 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 the 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

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• a sodium-restricted diet
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema, asthma 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

Ask a doctor or pharmacist before use if you are taking

• sedatives or tranquilizers
• the blood thinning drug warfarin

When Using This Product

• do not exceed recommended dosage
• 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 A Doctor If

• nervousness, dizziness, or sleeplessness occurs
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• symptoms do not get better or worsen
• 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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a heath care professional before use.

Otc - Keep Out Of Reach Of Children

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.

Directions

• do not use more than directed
• take every 4 hours; do not take more than 5 packets in 24 hours unless directed by a doctor

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

• 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.

Other Information

• each packet contains: potassium 4 mg, sodium 27 mg
• phenylketonurics: contains phenylalanine 34 mg per packet
• store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.

Inactive Ingredients

acesulfame potassium, aspartame, citric acid anhydrous, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch.

Questions Or Comments?

Call 1-866-923-4914

Principal Display Panel - 6 Packet Carton

RITE
AID_®
PHARMACY

SEE NEW WARNINGS INFORMATION & DIRECTIONS

*Compare to the active ingredients in
Theraflu^® Severe Cold & Cough

nighttime
severe cold
& cough relief

acetaminophen 650 mg
diphenhydramine HCl 25 mg
phenylephrine HCl 10 mg

pain reliever/fever reducer
antihistamine/
cough suppressant
& nasal decongestant

relieves:
nasal congestion
cough
runny nose
sneezing
body ache
sore throat pain
headache
fever

honey lemon infused with
chamomile & white tea flavors

6 PACKETS

PRINCIPAL DISPLAY PANEL - 6 Packet Carton - nighttime 01