Dolo-D Plus Oral suspension 115 ml

Dolo-D Plus Oral suspension 115 ml

Composition:
Active ingredients (per 5 ml):
- Ibuprofen 100 mg
- Pseudoephedrine HCl 15 mg
- Chlorpheniramine maleate 1 mg.
Inactive ingredients:
Citric acid monohydrate, microcrystalline cellulose and sodium carboxymethylcellulose (Avicel CL-611), glycerol, sodium benzoate, sucrose, macrogolglycerol hydroxystearate, xanthan gum, Ponceau 4R, cherry flavor (benzaldehyde, ethyl acetate, hexyl acetate, vanillin, isobutyl acetate), monopropylene glycol, purified water.
Description:
Dolo-D Plus is a triple-action preparation combining an analgesic/antipyretic (ibuprofen), a nasal decongestant (pseudoephedrine), and an antihistamine (chlorpheniramine).
It provides relief from fever, pain, nasal congestion, and allergy-related symptoms associated with common cold in children.
Indications for Use:
Temporary relief of: - fever - nasal congestion - headache - minor body aches - sore throat - sneezing - watery eyes - sinus pain.
Indicated for children 6-12 years of age.
Not for children under 6 years.
Dosage and Method of Administration:
Shake well before use.
Children 6-12 years (21.6-43 kg):
10 ml (2 teaspoons) every 6 hours, as needed-Maximum 4 doses per day.
- Do not use it for fever for more than 3 days or pain/cold symptoms for more than 5 days.
- Do not double the dose after a missed dose.
Contraindications:
- Children under 6 years - active peptic ulcer or GI inflammation
- Hypersensitivity to ibuprofen, NSAIDs, pseudoephedrine, chlorpheniramine
- ASA/NSAID-induced asthma, urticaria, anaphylaxis
- Severe hepatic impairment
- Severe renal impairment (CrCl <30 mL/min)
- Severe hypertension, severe coronary artery disease
- MAO inhibitors (concomitant or within 14 days)
- Hyperkalemia
- Systemic lupus erythematosus
- Pre-/post-heart surgery
- Thyroid disease
- Raynaud’s syndrome
- Pregnancy (third trimester).
Precautions
- Avoid use in diabetes, glaucoma, prostate enlargement unless advised
- Caution in heart failure, hypertension, or fluid retention
- Stop immediately if urinary symptoms occur
- Ibuprofen may mask signs of infection
- Not to be used with other NSAIDs
- May cause drowsiness; avoid alcohol
- Pseudoephedrine may increase BP and heart rate
- Risk of serious GI toxicity (ulceration, perforation, bleeding)
- Renal toxicity risk, especially with dehydration
- Potential for severe allergic reactions
- Caution in hepatic, renal, or cardiac impairment.
Side Effects:
- Drowsiness, dizziness - nervousness, insomnia - nausea, abdominal pain, constipation/diarrhea - dry mouth - hypertension, tachycardia, arrhythmias - allergic reactions - rare but serious skin reactions (SJS/TEN) - ischemic colitis cases reported with pseudoephedrine.
Pregnancy and Breastfeeding:
- For pediatric use only (6-12 years).
- Combination is contraindicated during the third trimester.
Storage Conditions:
Store below 30°C.
Keep out of the reach of children.
Packaging:
Carton box with 115 mL bottle, leaflet.