PREMIER VALUE MULTI-SYMPTOM SEVERE COLD GREEN TEA AND HONEY LEMON FLAVORS- acetaminophen, dextromethorphan hbr and phenylephrine hcl granule, for solution

Premier Value Multi-Symptom Severe Cold by

Drug Labeling and Warnings

Premier Value Multi-Symptom Severe Cold by is a Otc medication manufactured, distributed, or labeled by Premier Value. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Multi-Symptom Severe Cold with Green Tea and Honey Lemon flavors

Active ingredients (in each packet) Purpose

Acetaminophen 500 mg ........................................Pain reliever/Fever reducer

Dextromethorphan hydrobromide 20 mg ..............Cough suppressant

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

PURPOSE

Uses

- Temporarily relieves these symptoms due to a cold:

- minor aches and pains - headache - minor sore throat pain

- nasal and sinus congestion - 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: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician 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 nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.

- 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 - trouble urinating due to an enlarged prostate gland - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema.

ASK DOCTOR/PHARMACIST

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

INDICATIONS & USAGE

When using this product

- do not exceed recommended dosage.

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.

OVERDOSAGE

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

- 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 8 mg, sodium 15 mg, calcium 120 mg.

- phenylketonurics: contains phenylalanine 13 mg per packet

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

INACTIVE INGREDIENT

Acesulfame potassium, anhydrous citric acid, Aspartame, calcium phosphate dibasic, caramel, D and C yellow No. 10, flavors, Maltodextrin, silicon dioxide, Sodium Citrate, Starch, Sucrose.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREMIER VALUE MULTI-SYMPTOM SEVERE COLD  GREEN TEA AND HONEY LEMON FLAVORS
acetaminophen, dextromethorphan hbr and phenylephrine hcl granule, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-754
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ASPARTAME (UNII: Z0H242BBR1)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	yellow (Caramel color) , yellow (D and C Yellow No. 10)	Score
Shape		Size
Flavor	HONEY (Natural Honey and Lemon flavor) , LEMON (Natural Honey and Lemon Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-754-06	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)