MULTI SYMPTOM SEVERE COLD- acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
RARITAN PHARMACEUTICALS INC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/Fever reducer Cough Suppressant Nasal Decongestant
Authorization status:
OTC monograph final
Authorization number:
68163-547-06

MULTI SYMPTOM SEVERE COLD- acetaminophen, dextromethorphan hbr, phenylephrine

hcl powder, for solution

RARITAN PHARMACEUTICALS INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

DRx Choice Multi-Symptom Severe Cold Green Tea and Honey Lemon Flavors 6 Packets

Active ingredients (in each packet)

Acetaminophen 500 mg

Dextromethorphan hydrobromide 20 mg

Phenylephrine hydrochloride 10 mg

Purposes

Pain reliever/Fever reducer

Cough Suppressant

Nasal Decongestant

Uses

Warnings

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

Allergy alert : Acetaminophen may cause severe skin reactions, Symptoms may include:

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

temporarily relieves these symptoms due to a cold:

minor aches and pains

minor sore throat pain

headache

nasal and sinus congestion

cough due to minor throat and bronchial irritation

temporarily reduces fever

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

skin reddening

blisters

Rash

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

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not exceed recommended dosage

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Prompt medical attention is critical for adults as well as for children even if you do not notice any signs

or symptoms.

in a child under 12 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 a pharmacist.

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.

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

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.

Directions

Dose

Adults and children 12 years of age and over

One packet

Children under 12 years of age

Do not use

Other information

Inactive ingredients

citric acid, caramel, flavors, maltodextrin ,potassium chloride, silica, sucralose, sucrose,

Questions or Comments

1-866-467-2748

Principal Display

DRx Choice®

NDC# 68163-547-06

Compare to the active ingredients in Theraflu

Multi-Symptom Severe Cold*

MULTI-SYMPTOM

Severe Cold

ACETAMINOPHEN -

Pain Reliever/ Fever Reducer

DEXTROMETHORPHAN HBr -

Cough Suppressant

PHENYLEPHRINE HCl -

Nasal Decongestant

do not use more than directed

take every 4 hours, while symptoms persist. 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.

each packet contains: potassium 6 mg

store at room temperature. Protect from excessive heat and moisture.

Aspartame Free

Dye free

Sodium free

Relieves

Green Tea & Honey Lemon Flavors

Infused with Menthol & Green Tea Flavors

6 PACKETS

TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR

BROKEN.

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court,

East Brunswick, NJ 08816

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of

Theraflu

Multi-Symptom Severe Cold.

Body ache

Cough

Fever

Headache

Nasal congestion

Sore throat pain

MULTI SYMPTOM SEVERE COLD

acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 16 3-547

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

50 0 mg

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

20 mg

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

10 mg

RARITAN PHARMACEUTICALS INC

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

CARAMEL (UNII: T9 D9 9 G2B1R)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

PO TASSIUM CHLO RIDE (UNII: 6 6 0 YQ9 8 I10 )

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

SUCRO SE (UNII: C151H8 M554)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

HONEY (Green Tea and Ho ney Lemo n)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 16 3-547-0 6

6 in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct

0 4/10 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 4/10 /20 19

Labeler -

RARIT AN PHARMACEUT ICALS INC (127602287)

Revised: 8/2020

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