Coldrex HotRem powder, for colds and flu, with lemon and honey flavor, 10 sachets

Sachet contents Heterogeneous powder from grayish-white with a beige tint to light brown with white, light brown and dark brown inclusions.

Solution in hot water Turbid solution from light yellow to light brown with insoluble white inclusions and a characteristic smell of lemon and honey.

Pharmaco-therapeutic group

N4 The drug is used as a temporary remedy for the elimination of cold and flu symptoms, including: fever

headache

chills

joint and muscle pain

sinus pain and congestion

sore throat.

Application during pregnancy and during breastfeeding

Adequate and strictly controlled studies of the use of the drug during pregnancy and during breastfeeding have not been conducted.

In animal studies in late gestation, phenylephrine delayed fetal growth and stimulated early labor.

Phenylephrine can pass into breast milk.

There is no data on the use of drugs containing phenylephrine during breastfeeding.

The use of the drug during pregnancy and during breastfeeding is contraindicated.

If necessary, the use of the drug during lactation, breastfeeding should be discontinued.

Dosage form

Powder for preparation of oral solution (lemon-honey).

5 g of powder in a laminate bag (paper / polyethylene / aluminum foil / polyethylene).

For 3, 5 or 10 sachets, together with instructions for use in a cardboard box.

On the secondary packaging, it is allowed to have a first opening control.

Shelf life

3 years.

Do not use after the expiration date printed on the package.

Category

Symptomatic drugs

Dosage

60mg + 750mg + 10mg x 5g

Structure

Composition for 1 sachet:

Component name

Quantity, mg

Active ingredients

Paracetamol

750.00

Phenylephrine hydrochloride

10.00

Vitamin C

one

60,00

Excipients

Anhydrous citric acid

600.00

Sodium saccharinate

10.00

Sodium citrate

500.00

Lemon Flavor PHS-163671

100,00

Flavor honey PFW PHS-050860

75.00

Felton honey flavor F7624P

125,00

Caramel color 626

50,00

Corn starch

200,00

Aspartame

50,00

Sucrose

2468.50

Powder weight

5000.00

1 - coated with ethylcellulose (less than 0.03% of the total weight of the powder in 1 sachet)

INN / Active ingredient

Paracetamol + Phenylephrine + [Ascorbic acid]

Storage conditions and periods

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Specifications

Category

Pain and fever

Release form

Powder

Manufacturer country

Spain

Vacation conditions

Without recipe

Brand name

Coldrex

The amount of the dosage form in the primary package

5 g

Primary packaging type

Sachet (sachet)

Type of consumer packaging

Pack of cardboard

Packaging

Box

The target audience

Children

A type

Medicine

Package weight, g

one hundred

Dosage (volume) of the substance in the preparation

:

1 package: Paracetamol 750 mg.

Phenylephrine hydrochloride 10 mg.

Ascorbic acid 60 mg

Mode of application

:

For oral administration. Do not exceed the recommended dose! The smallest dose necessary to achieve the effect should be used for the shortest possible period of treatment! The minimum interval between doses of Coldrex HotRem should be at least 4 hours. Pour the contents of 1 sachet into a mug, pour about 250 ml of hot water and mix thoroughly. Add cold water and sugar if necessary. Adults and children over 12 years old 1 sachet every 4-6 hours, but not more than 4 sachets per day. The maximum duration of the drug use without consulting a doctor should be no more than 5 days. It is not recommended to use the drug as an antipyretic agent for more than 3 days without consulting a doctor. It is not recommended to use simultaneously with other paracetamol-containing agents,decongestants and remedies for the relief of cold and flu symptoms, as well as ethanol-containing products and drinks. If, while taking the drug, symptoms of the disease persist, you should consult a doctor. If the recommended dose is exceeded, seek immediate medical attention, even if you feel well, as there is a risk of delayed serious liver damage. Paracetamol overdose can cause liver and / or kidney failure. Special groups of patients Patients with impaired renal function Before using Coldrex HotRem, patients with impaired renal function should first consult a doctor. Restrictions associated with the use of preparations containing such a combination of active substances,in patients with impaired renal function, they are mainly associated with the content of paracetamol in the drug. Patients with impaired liver function Before using Coldrex HotRem, patients with impaired liver function should first consult a doctor. Restrictions associated with the use of drugs containing this combination of active substances in patients with impaired liver function are mainly associated with the content of paracetamol in the drug.in patients with impaired liver function, they are mainly associated with the content of paracetamol in the drug.in patients with impaired liver function, they are mainly associated with the content of paracetamol in the drug.

Pharmaco-therapeutic group

:

ARI and cold" symptoms remedy (analgesic non-narcotic drug + alpha-adrenergic agonist + vitamin)

Anatomical and therapeutic characteristics

:

N02BE51 Paracetamol, in combination with other drugs (excluding psychotropic drugs)

Dosage form

:

Powder for solution for oral administration [honey-lemon]

Information on technical characteristics, delivery set, country of manufacture "