CAREONE DAYTIME SEVERE COLD AND COUGH BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS- acetaminophen, dextromethorphan hbr and phenylephrine hcl granule, for solution

CareOne Daytime Severe Cold and Cough by

Drug Labeling and Warnings

CareOne Daytime Severe Cold and Cough by is a Otc medication manufactured, distributed, or labeled by American Sales Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Daytime Severe Cold and Cough Berry infused with Menthol and Green Tea flavors

Active ingredients (in each packet)                              Purpose
Acetaminophen 650 mg ........................................Pain reliever/Fever reducer
Dextromethorphan hydrobromide 20 mg ..............Cough suppressant
Phenylephrine hydrochloride 10 mg.......................Nasal decongestant.

PURPOSE

Uses

- Temporarily relieves:

    - 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.
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

- 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   - 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.

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

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.
- adults and children 12 years of age and over: dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
- children under 12 years of age: consult a doctor.
- 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 20 mg
- phenylketonurics: contains phenylalanine 14 mg per packet
- store at controlled room temperature 20-25C (68-77F). Protect from excessive heat and moisture.

INACTIVE INGREDIENT

Acesulfame K, Aspartame, Citric Acid, FD and C Blue No. 1, FD and C Red No. 40, Maltodextrin, Menthol, Natural Flavors, Sodium Citrate, Starch and Sugar.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREONE DAYTIME SEVERE COLD AND COUGH  BERRY INFUSED WITH MENTHOL AND GREEN TEA FLAVORS
acetaminophen, dextromethorphan hbr and phenylephrine hcl granule, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-330
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 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 (UNII: MA3UYZ6K1H)
ASPARTAME (UNII: Z0H242BBR1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	red (FD and C red No. 40) , blue (FD and C blue No. 1)	Score
Shape		Size
Flavor	BERRY (Berry infused with menthol and green tea flavors) , MENTHOL (menthol)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-330-06	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	07/31/2013

Labeler - American Sales Company (809183973)