Ascorbic acid powder

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ascorbic acid

Available from:

Alliance Healthcare (Distribution) Ltd

ATC code:

A11GA01

INN (International Name):

Ascorbic acid

Dosage:

1mg/1mg

Pharmaceutical form:

Not applicable

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09060301

Patient Information leaflet

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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paracetamol, Ascorbic acid, Phenylephrine Hydrochloride 750/60/10 mg
blackcurrant
flavoured Powder for Oral solution.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5.0 g sachet of powder for oral solution contains:
ACTIVE CONSTITUENTS:
Paracetamol
750.0 mg
Ascorbic Acid
60.0 mg
Phenylephrine Hydrochloride
10.0 mg
EXCIPIENTS:
Sucrose
2725 mg
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Powder for oral solution
Pale purple coloured powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short term symptomatic relief of influenza, feverishness, chills and
colds including
headache, sore throat pain, aches and pains, nasal congestion,
sinusitis and its
associated pain and acute nasal catarrh.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration, dissolved in hot water.
Dosage:
Adults (including elderly) aged 16 years and over:
One sachet in a tumbler full of hot water to be taken every four to
six hours up to four
times a day.
Children:
Not recommended for children under 16 years of age.
Do not take continuously for more than 5 days without medical advice.
4.3
CONTRAINDICATIONS
Hypersensitivity to paracetamol or any of the other constituents.
Concomitant use of other sympathomimetic decongestants.
Phaeochromocytoma.
Closed angle glaucoma.
Hepatic or severe renal impairment, hypertension, hyperthyroidism,
diabetes, heart
disease. Patients taking tricyclic antidepressants, or beta-blocking
drugs and those
patients who are taking or have taken, within the last two weeks,
monoamine oxidase
inhibitors (see section 4.5).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Care is advised in the administration of paracetamol to patients with
renal or hepatic
impairment. The hazard of overdose is greater in those with
non-cirrhotic alcoholic
liver disease.
Medical advice should be sought before taking this product in patients
with these
conditions:
•
An enlargement of the prostate gland
•
Occulusive Vascular disease (e.g. R