PREMIER VALUE NIGHT TIME SEVERE COLD AND COUGH HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS- acetaminophen, diphenhydramine hcl, and phenylephrine hcl. granule, for solution

Premier Value night time severe cold and cough by

Drug Labeling and Warnings

Premier Value night time severe cold and cough by is a Otc medication manufactured, distributed, or labeled by Premier Value. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each packet)                          Purpose

Acetaminophen 650 mg .......................................Pain reliever/Fever reducer

Diphenhydramine hydrochloride 25 mg ........Antihistamine/Cough suppressant

Phenylephrine hydrochloride 10 mg .................................Nasal decongestant

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 and throat - itchy, watery eyes due to hay fever

- cough due to minor throat and bronchial irritation

- temporarily reduces fever

WARNINGS

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 - with other drugs containing acetaminophen - 3 or more alcoholic drinks every day while using this product

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.

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

Do not use

- In a child under 4 years of age

- If you are allergic to Acetaminophen

- with any other drug containing acetaminophen (prescription and non prescription). 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 a MAOI, ask a doctor or pharmacist before taking this product.

ASK DOCTOR

Ask a doctor before use if you have

- liver disease - heart disease - high blood pressure

- thyroid disease - diabetes - glaucoma

- 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.

- a sodium restricted diet.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

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

INDICATIONS & USAGE

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

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.

PREGNANCY OR BREAST FEEDING

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

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.

DOSAGE & ADMINISTRATION

Directions

- do not use more than directed

- take every 4 hours; not to exceed 6 packets in 24 hours or as 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.

INFORMATION FOR PATIENTS

Other information

- each packet contains: potassium 7 mg, sodium 46 mg

- phenylketonurics: each packet contains phenylalanine 13 mg

- store at controlled room temperature 20-25C (68-77F). Protect from heat and moisture.

INACTIVE INGREDIENT

Acesulfame potassium, anhydrous citric acid, aspartame, caramel, D and C Yello 10, maltodextrin, natural flavors, sodium citrate, starch and sugar.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREMIER VALUE NIGHT TIME SEVERE COLD AND COUGH  HONEY LEMON INFUSED WITH CHAMOMILE AND WHITE TEA FLAVORS
acetaminophen, diphenhydramine hcl, and phenylephrine hcl. granule, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-755
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME (UNII: MA3UYZ6K1H)
ASPARTAME (UNII: Z0H242BBR1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	yellow (Carmel Color) , yellow (D & C Yellow 10)	Score
Shape		Size
Flavor	HONEY (Natural Honey & Lemon Flavor) , LEMON (Natural Honey & Lemon Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-755-06	6 in 1 BOX; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/24/2016

Labeler - Premier Value (101668460)